While there were FDA setbacks for Calliditas and Verrica last month there were also a couple of early oncology approvals. One such win was for Tivdak, Seagen/Genmab’s treatment for recurrent or metastatic cervical cancer. However, expected sales of Tivdak could be hit by an unexpected black box warning regarding ocular toxicity. An early approval for Takeda’s Exkivity also came with safety implications. The oral therapy, used to treat lung cancer driven by EGFR exon 20 insertions, has a black box warning for QTc prolongation. J&J’s competing project Rybrevant does not come with a warning, but is less convenient as it is an infused antibody. Separately, Takeda investors are still holding out for FDA news on Eohilia after the FDA's action date was missed in April. Takeda says Eohilia could become the first treatment for eosinophilia oesophagitis, but with a filing for Sanofi/Regeneron’s Dupixent expected next year Takeda will want the regulators to hurry.
| Notable first-time US approval decisions in September | ||||
|---|---|---|---|---|
| Project | Company | Indication(s) | 2026e sales by indication ($m) | Outcome |
| Qulipta (atogepant) | Abbvie | Episodic migraine prevention | 954 | Approved |
| Tivdak (tisotumab vedotin) | Seagen/Genmab | Previously treated recurrent or metastatic cervical cancer | 629* | Accelerated approval (over 2 weeks early) |
| Nefecon | Calliditas | IgA nephropathy | 629** | Extended to Dec 15 |
| Exkivity (moborcertinib) | Takeda | EGFR exon 20 Insertion+ NSCLC | 436 | Accelerated approved (over a month early) |
| Livmarli (maralixibat) | Mirum | Cholestatic pruritus in Alagille syndrome | 432 | Approved |
| VP-102 | Verrica | Molluscum contagiosum | 271* | Second CRL (deficiencies at contract manufacturer) |
| Eohilia (TAK-721) | Takeda | Eosinophilic esophagitis | 187 | No decision yet (April Pdufa missed) |
| Illuccix | Telix | Prostate cancer imaging | 42 | Extended to December 23 |
| Reltecimod | Atox Bio | Resolution of organ dysfunction in necrotising soft tissue infections | - | Supposed to have been Sep 30, no news released |
| Epsolay | Sol-Gel | Papulopustular rosacea | - | No decision yet (delayed in Apr) |
| *Sales by indication not split out, **includes undisclosed partner sales. Source: Evaluate Pharma & company releases | ||||
| Supplementary and other notable approval decisions in September | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| AVT02 (Humira biosimilar) | Alvotech/Teva | Inflammatory conditions, PK study AVT02-GL-101, efficacy study AVT02-GL-301 | Delayed (facility inspection) |
| Repatha | Amgen | Paediatric patients with heterozygous familial hypercholesterolemia (Hauser-RCT) | Approved |
| Invega Hafyera (Paliperidone palmitate 6-month, PP6M) | J&J | Adults with schizophrenia (Route 6) | Approved |
| INP104/ Trudhesa | Impel | 505(b)(2) application acute treatment of migraine (dihydroergotamine mesylate with olfactory delivery) | Approved |
| Brukinsa | Beigene | Marginal zone lymphoma who have received at least one prior anti-CD20-based therapy (Magnolia, Ph1/2) | Approved |
| Brukinsa | Beigene | Waldenström’s macroglobulinemia (Aspen) | Approved |
| Opzelura (ruxolitinib cream) | Incyte | Atopic dermatitis (TruE-AD1, TruE-AD2) | Approved |
| Jakafi | Incyte/Novartis | Paediatric patients with steroid-refractory GvHD (Reach3) | Approved |
| Byooviz (Lucentis biosimilar) | Biogen/ Samsung Bioepis | Wet AMD, myopic choroidal neovascularisation and macular oedema following retinal vein occlusion | Approved |
| Erbitux + Braftovi | Lilly/Pfizer | Adult patients with metastatic colorectal cancer with a BRAF V600E mutation (Beacon CRC) | Approved |
| Source: Evaluate Pharma, company releases & clinicaltrials.gov https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-september-0 | |||
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