Roche’s bispecific antibody Vabysmo swayed the regulators last month, but now has to make headway in a competitive space dominated by Regeneron and Bayer’s Eylea. Vabysmo was approved for both wet age-related macular degeneration and diabetic macular oedema, with Roche hoping to exploit the therapy's less frequent dosing. However, Regeneron/Bayer have their defences ready: data on a higher dose version of Eylea are due in the second half of the year. Elsewhere the FDA dished out complete response letters for Pfizer/Opko’s somatrogon and Merck & Co’s gefapixant. The latter is a P2X3 receptor antagonist being tested in chronic cough, and the knockback came as regulators requested further information on efficacy. Bellus Health’s competing project BLU-5937 has had its ups and downs in early trials, but phase 3 will be the real test, with studies due to start this year.
| Notable first-time US approval decisions in January | ||||
|---|---|---|---|---|
| Project | Company | Indication(s) | 2026e sales by indication ($m) | Outcome |
| Spikevax | Moderna | Prevention of Covid-19 (18 years of age and older) | 3,686 | Approved (gained EUA Dec 2020) |
| Vabysmo (faricimab) | Roche | wAMD, DME | 1,129 | Approved |
| 177Lu-PSMA-617 | Novartis | Radioligand therapy for mCRPC | 851 | No decision yet, guided to H1 |
| Cibinqo | Pfizer | Atopic dermatitis | 760 | Approved |
| Quviviq (daridorexant) | Idorsia | Insomnia | 531 | Approved |
| Somatrogon (hGH-CTP) | Pfizer/Opko | Growth hormone deficiency | 113 | CRL |
| Oteseconazole (VT-1161) | Mycovia | Recurrent vulvovaginal candidiasis | - | Not yet disclosed |
| Zonisamide oral suspension | Azurity/Eton | Partial seizures in patients with epilepsy | - | Not yet disclosed |
| Ryaltris nasal spray | Glenmark/ Hikma | Seasonal allergic rhinitis | - | Approved (CRL in 2019) |
| Gefapixant | Merck | Refractory chronic cough or unexplained chronic cough in adults | - | CRL (additional info related to efficacy) |
| Kimmtrak (Tebentafusp/IMCgp100) | Immunocore | HLA-A*02:01-positive unresectable or metastatic uveal melanoma | - | Approved (~1 month early) |
| Source: Evaluate Pharma & company releases. | ||||
| Supplementary and other notable approval decisions in January | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Lynparza | Astrazeneca | Adjuvant Brca-mutated Her2-negative breast cancer (OlympiA) | No decision yet, guided to Q1 |
| Fasenra | Astrazeneca | Nasal polyps | No decision yet, guided to H1 |
| Rinvoq | Abbvie | Refractory, moderate to severs atopic dermatitis in adults and children aged 12 and over (Measure Up 1 & 2, AD Up) | Approved |
| Skyrizi | Abbvie | Active psoriatic arthritis (Keepsake-1 & Keepsake-2) | Approved |
| Veklury | Gilead | Certain non-hospitalised adults and paediatric patients for the treatment of mild-to-moderate Covid | Approved |
| Olumiant | Lilly | Atopic dermatitis (Breeze-AD programme) | Potential for CRL |
| Libtayo | Regeneron/ Sanofi | Recurrent/met cervical cancer whose disease progressed on or after chemotherapy (Empower-Cervical 1) | Withdrawn |
| Source: Evaluate Pharma & company releases. https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-january | |||
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