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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