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. https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-february | ||
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