US FDA approval tracker: September

Snippets

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

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