2022, FDA Approval and Licensing - Drug Discovery Digest

2022

FDA Approval

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Tofersen

New Drug Approvals

MAY 17, 2025

3] Tofersen was approved for medical use in the United States in April 2023, [3] [6] and in the European Union in May 2024. [4] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Food and Drug Administration (FDA). January 2022). 25 April 2023. Retrieved 10 June 2023.

FDA Approval

FDA Approval FDA Treatment Clinical Trials

Inavolisib

New Drug Approvals

APRIL 25, 2025

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 3] Inavolisib was approved for medical use in the United States in October 2024. [3] 2022 Dec 22;65(24):16589-16621. Epub 2022 Dec 1. Food and Drug Administration (FDA). December 2022). J Med Chem. doi: 10.1021/acs.jmedchem.2c01422.

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Vamorolone

New Drug Approvals

JULY 25, 2025

Syn EuropeanJournalofMedicinalChemistry265(2024)116124 Vamorolone (Agamree) On October 26, 2023, Vamorolone, developed jointly by Santhera Pharmaceuticals and ReveraGen BioPharma, has received FDA approval to treat DMD in patients aged 2 years and older [1]. 79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. Shale, U.J.

FDA

FDA FDA Approval Treatment Clinical Trials

Pirtobrutinib

New Drug Approvals

MAY 8, 2025

Food and Drug Administration (FDA). FDA Approves Jaypirca (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor” (Press release). eCollection 2022.

FDA Approval

FDA Approval FDA Therapies Trials

Elacestrant

New Drug Approvals

MAY 9, 2025

2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Jump up to: a b c d e f g “FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. Food and Drug Administration (FDA). 8 February 2023. 27 January 2023.

FDA

FDA Pharmacokinetics Therapies Treatment

Sebetralstat

New Drug Approvals

JULY 10, 2025

. ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). October 2022). PMID 36251573. ^ “Sebetralstat Orphan Drug Designations and Approvals” U.S. Food and Drug Administration (FDA).

FDA

FDA Treatment Small Molecule International

Crinecerfont

New Drug Approvals

APRIL 18, 2025

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).

FDA

FDA FDA Approval Drugs Trials

Landiolol

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 21 December 2022. 24 August 2022. FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release).

FDA

FDA Clinical Trials Treatment Trials

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Therapies FDA FDA Approval Treatment

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

DECEMBER 13, 2020

During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting.

Licensing

Licensing Licensing Clinical Trials FDA

Olutasidenib

New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1 December 2022. J Med Chem.

FDA Approval

FDA Approval FDA Treatment Pharmaceuticals

Economic Theory Explains Big Pharma Scare Tactics on Importation

Policy Prescription

OCTOBER 3, 2023

That’s why, according to Salant, drug companies “[blur] the distinction between dangerous counterfeit drugs and safe drugs sold by pharmacies licensed in other high-income countries.” In the summer of 2022, a policy debate in the Senate HELP committee ensued with Sens. but negotiate higher prices in foreign markets.

Pharmacy

Pharmacy International Government FDA Approval

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

December 2022). S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634.

Clinical Trials

Clinical Trials FDA Clinical Pharmacology FDA Approval

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] July 2022). 1] It is taken by mouth. [1] 401 (10383): 1159–1171.

FDA

FDA FDA Approval International Pharmacokinetics

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. FDA-2022-E-3124 ). 6,992,207 covering PEPAXTO (Docket No.

FDA

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Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

The Pharma Data

MARCH 27, 2022

In February 2022, the U.S. Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. European Union and Japan in 2022. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata.

Licensing

Licensing Licensing Disease FDA Approval

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

Trials

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Iptacopan

New Drug Approvals

DECEMBER 16, 2023

August 2022). 1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. . 5 December 2023. . twitter +919321316780 call whatsaapp EMAIL.

FDA

FDA Small Molecule FDA Approval Treatment

Teva Announces Settlement with Lupin Resolving AUSTEDO® (deutetrabenazine) Patent Dispute

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. On March 9, 2022, the U.S.

Pharmaceuticals

Pharmaceuticals Production Treatment Disease

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Agency IQ

APRIL 26, 2024

Can information about a biosimilar product be included in promotional materials, even if it isn’t specifically included in the product’s actual FDA-approved labeling? Information regarding interchangeability would remain available only in the Purple Book: Database of Licensed Biological Products. Yes, the guidance confirms.

Biosimilars

Biosimilars Science FDA Licensing

Deuruxolitinib

New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

FDA Approval

FDA Approval FDA Treatment Clinical Trials

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018.

FDA

FDA Treatment Drugs FDA Approval

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA

FDA Biosimilars Science Drugs

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

FDA

FDA FDA Approval Marketing Production

Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

Treatment

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Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

Biosimilars

Biosimilars FDA Production Treatment

Veklury® (Remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19

The Pharma Data

APRIL 26, 2022

These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). Veklury was approved by the FDA in October 2020, for adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Gilead Sciences, Inc.

Treatment

Treatment Hospitals Science Licensing

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog: Biosimilars

MAY 5, 2024

Background In October 2022, President Biden directed the Health and Human Services (“HHS”) Secretary and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” After the public comment period closes, DEA will review comments and issue a final rule.

FDA

FDA Regulations Treatment Licensing

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

FDA’s is generally consistent from edition to edition , will each edition consisting primarily of holdovers from previous editions. The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Read our analysis of that rule here and here. ]

Regulations

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FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularis

The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

FDA

FDA Disease Trials FDA Approval

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. Regulatory filings around the world are also planned in 2022. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S.

FDA

FDA Treatment Disease FDA Approval

BioSpace Global Roundup: Cevec Licenses AAV Program to Biogen

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. Top-line results are expected in the first half of 2022.

Licensing

Licensing Licensing Clinical Trials Vaccine

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Read Economic terms were compared for 239 biotechnology licenses issued to academic institutions and 916 similar licenses at commercial firms. from 2021 to 2022, up to $625 million. Will Bedingfield.

DNA

DNA RNA Engineering Licensing

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tezepelumab. Rozibafusp alfa (AMG 570). Olpasiran (AMG 890).

Biosimilars

Biosimilars Production Treatment FDA

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science

Science FDA Production Packaging

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. November is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication.

FDA

FDA Disease Treatment FDA Approval

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. OIRA eventually released the rule for release by the FDA (with changes) on May 10, 2023.

FDA

FDA FDA Approval Production Regulations

Zavegepant

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. doi : 10.2217/pmt-2022-0054. . 10 March 2023.

Clinical Trials

Clinical Trials Treatment Trials FDA

Where's the Synthetic Blood?

Codon

JULY 14, 2024

In January 2022, the American Red Cross declared its first-ever national blood crisis owing to a severe blood shortage—the worst shortfall in more than a decade. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial.

Production

Production Clinical Trials Trials Therapies

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

Even though President Joe Biden had asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” in October 2022 , we also wondered how the Department of Justice (“DOJ”) and DEA would receive the HHS recommendation. Basis at 63-64.

Regulations

Regulations FDA Drugs Treatment

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Read our analysis of the lawsuit against the drug importation rule here. ]

FDA Approval

FDA Approval FDA Science Drugs

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Tofersen

Inavolisib

Trending Sources

Vamorolone

Pirtobrutinib

Elacestrant

Sebetralstat

Crinecerfont

Landiolol

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

Olutasidenib

Economic Theory Explains Big Pharma Scare Tactics on Importation

Eplontersen

Etrasimod

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly’s Lebrikizumab Atopic Dermatitis Monotherapy Trials

Iptacopan

Teva Announces Settlement with Lupin Resolving AUSTEDO® (deutetrabenazine) Patent Dispute

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Deuruxolitinib

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Veklury® (Remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

DEA Concurs: Marijuana Meets Schedule III Criteria

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularis

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

BioSpace Global Roundup: Cevec Licenses AAV Program to Biogen

Codon Digest: Injected Gene Editors

Amgen Reports Second Quarter 2021 Financial Results

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Zavegepant

Where's the Synthetic Blood?

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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