US FDA approval tracker: October

Snippets

The Covid-19 pandemic saw the FDA give full approval to Gilead’s Veklury last month despite contradictory evidence of its efficacy in hospitalised patients. Sales of the drug are forecast to peak at $3bn next year according to sellside consensus from EvaluatePharma, but with Covid-19 increasingly affecting younger, healthier patients Veklury’s use could be limited. Elsewhere, Kala received the greenlight for its dry eye treatment, Eysuvis. The next hurdle for Kala will be launching during a pandemic given most patients would likely avoid in-person physician visits for non-essential treatment. Avenue Therapeutics, meanwhile, received a knockback for its intravenous version of the opioid painkiller tramadol due to safety concerns. Avenue’s shares plummeted 59% on the news. Zosano also got a complete response letter for its migraine treatment Qtrypta, a transdermal microneedle system that delivers zolmitriptan. Due to differences observed in zolmitriptan exposures in trial subjects the FDA requested a repeat bioequivalence study between three of the product lots used during development.

Notable first-time US approval decisions in October
Project Company 2026e sales by indication ($m) Outcome
Veklury
(remdesivir)
Gilead 1,729 Approved
Eysuvis Kala Pharmaceuticals 1,118 Approved
Rolontis/
eflapegrastim
Spectrum 314 Action deferred due to Covid-19 travel restrictions
Qtrypta Zosano 286 CRL
IV tramadol Avenue Therapeutics/Fortress Biotech 281 CRL
Inmazeb
(REGN-EB3)
Regeneron - Approved
Sources: EvaluatePharma & company releases.

 

October advisory committee meeting outcomes
Project Company 2026e sales by indication ($m) Outcome Vantage story
ALKS 3831 Alkermes 362 Positive Could Alkermes’ new antipsychotic punch below its weight?
AR19
(immediate release amphetamine capsule)
Arbor - Negative -
Vaccines and related biological products - NA - US panel puts the spotlight on pivotal Covid vaccine readouts
Sources: FDA ad com calendar, EvaluatePharma.

 

Supplementary and other notable approval decisions in October
Product Company Indication (clinical trial) Outcome
Keytruda Merck & Co 2nd line treatment R/R classical HL (Keynote-204 vs Seattle's Adcetris) Approved
Opdivo + Yervoy Bristol Myers Squibb Untreated unresectable malignant pleural mesothelioma (Checkmate-743) Approved
Generic Nuvaring Mayne Pharma Group Contraception CRL
Wakix Harmony Biosciences Cataplexy in adult patients with narcolepsy (Harmony  CTP, Harmony 1) Approved
Sources: EvaluatePharma & company releases.  

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