US FDA approval tracker: February

The last day of February brought FDA joy for Johnson & Johnson, Legend Biotech and CTI Biopharma but anguish for Gilead and Amryt. The latter's epidermolysis bullosa therapy, Oleogel-S10, was knocked back with the FDA requesting additional confirmatory evidence of efficacy, and it is not yet known whether Amryt will need to run another trial. Meanwhile, Gilead’s lenacapavir was turned down owing to vial compatibility issues; the drug had been filed in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. In December ten clinical studies, including Purpose-1 and 2 in pre-exposure prophylaxis, were put on hold due vial concerns. The long-acting HIV-1 capsid inhibitor is seen as an important pipeline asset for Gilead and was expected to be one of the biggest launches of 2022, but approval this year now looks very uncertain. J&J and Legend's Car-T agent, newly approved for multiple myeloma, is also slated as one of this year's biggest launches. The developers believe that last month's green light is only the beginning for Carvykti, and expect peak sales to reach at least $5bn, assuming success is achieved in earlier lines of therapy.   

Notable first-time US approval decisions in February
Project Company Indication(s) 2026e sales by indication (SBI) ($m) Outcome
Carvykti (ciltacabtagene autoleucel/cilta-cel)  Johnson & Johnson/
Legend Biotech
3L+ multiple myeloma 1,692 Approved
Lenacapavir Gilead Multi-drug resistant HIV in heavily treatment experienced patients  877 CRL (vial compatibility issues)
177Lu-PSMA-617  Novartis Radioligand therapy for mCRPC 851 Pending, expected H1
Enjaymo (sutimlimab) Sanofi Haemolysis in adults with cold agglutinin disease 440 Approved
Vonjo
(Enpaxiq/pacritinib)
CTI Biopharma Myelofibrosis patients with severe thrombocytopenia 368 Approved
Priorix GSK MMR vaccine 364 Pending
Pyrukynd
(mitapivat)
Agios PK deficiency 287 Approved
Oleogel-S10
(Filsuvez)
Amryt Junctional and dystrophic epidermolysis bullosa 269 CRL (additional confirmatory evidence needed)
Bardoxolone Reata Alport syndrome - CRL (provide evidence of effectiveness)
GC5107
(immune globulin intravenous, 10% liquid)
GC Pharma Primary humoral immunodeficiency - CRL (pre-license inspection)
d-amphetamine transdermal system
(ATS)
Noven/
Hisamitsu
ADHD - Pending
Annik
(penpulimab)
Akeso/Sino 3rd-line nasopharyngeal carcinoma - Pending, expected H1
Terlipressin Mallinckrodt Hepatorenal syndrome - Second CRL (manufacturing facility inspection)
Zynquista (sotagliflozin) Lexicon Heart failure in adults with type 2 diabetes - NDA filing withdrawn due to technical issue, resbumission targeted for Q2
Source: Evaluate Pharma & company releases.

 

Advisory committee meetings in February
Project Company Indication 2026e SBI ($m) Outcome
Comirnaty Pfizer/Biontech Amend the EUA for administration to children 6 months through 4 years of age 7,668 Postponed, waiting for three-dose data (expected in April)
Tyvyt (sintilimab) +
pemetrexed +
platinum chemotherapy 
Lilly/
Innovent
1L stage IIIB, IIIC, or Stage IV non-squamous NSCLC - 14-1 against, Pdufa March 22
IV tramadol Avenue Acute pain - 14-8 against
Source: Evaluate Pharma, FDA ad com calendar company releases.

 

Supplementary and other notable approval decisions in February
Product Company Indication (clinical trial) Outcome
Generic Restasis
(cyclosporine)
Viatris Increase tear production in patients with dry eye Approved (first FDA generic)
Solosec Lupin Pharma Treatment of bacterial vaginosis and trichomoniasis  in patients aged 12  and older Approved
Jardiance Eli Lilly/Boehringer Ingelheim Heart failure regardless of left ventricular ejection fraction (Emperor-Preserved) Approved
Generic Farxiga (dapagliflozin) Zydus Type 2 diabetes Final approval
Ruzurgi Jacobus Pharmaceutical Paediatric patients with Lambert-Eaton myasthenic syndrome Revoked, as approval violated Catalyst's exclusivity for Firdapse
Kymriah Novartis r/r FL after two prior lines of treatment (Ph2 Elara) Pending
Lynparza Astrazeneca Adjuvant BRCA-mutated Her2-negative breast cancer (OlympiA) Pending, expected Q1
Fasenra Astrazeneca Nasal polyps Pending, expected H1
Olumiant Lilly Atopic dermatitis (Breeze-AD programme) Pending
Rinvoq Abbvie Psoriatic arthritis, ankylosing spondylitis and ulcerative colitis  UC decision expected March, Q2 for ankylosing spondylitis and Q4 for non-radiographic axial SpA
Source: Evaluate Pharma & company releases. 

 

FDA issued EUAs to treat Covid-19
Project Company Setting
Bebtelovimab
(LY-CoV1404)
Eli Lilly For certain non-hospitalised patients with mild-to-moderate Covid-19 at high risk of progression to severe disease 
Source: Evaluate Pharma & company releases. 

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