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US FDA approval tracker: August

September 3, 2020

The FDA bared its teeth last month, delivering knockbacks for Biomarin, Gilead and Galapagos that took investors by surprise. Biomarin’s market cap lost $7.5bn on the rejection of its haemophilia A gene therapy candidate Roctavian (valrox). There have been questions over the project’s durability, and the regulator demanded two years’ data from an ongoing phase III study. The FDA also requested additional data on Gilead and Galapagos’ filgotinib, a Jak1 inhibitor. Readout from two studies investigating the drug’s impact on testicular toxicity aren’t due until next year, pushing filgotinib even further behind in a crowded rheumatoid arthritis market. Elsewhere, a panel voted unanimously against adding a mortality benefit to the COPD label for GSK’s Trelegy Ellipta. Despite the setback analysts believe that exacerbation benefits already detailed on the label are sufficient to continue to drive uptake in COPD. The respiratory drug has other tricks up its sleeve – a regulatory decision in asthma is awaited and, while Trelegy’s sales are driven by COPD, an approval here would be an added bonus.

Notable first-time US approval decisions in August
ProjectCompany2026e sales by indication ($m)Outcome
Evrysdi (risdiplam)Roche/PTC 1,786Approved
Jyseleca (filgotinib)Gilead/Galapagos1,404CRL
Roctavian (valoctocogene roxaparvovec/valrox) Biomarin1,365CRL
Blenrep (belantamab mafodotin)GSK/Seattle Genetics1,262Approved
Viltepso (viltolarsen)Nippon585Approved
Viaskin PeanutDBV556CRL
DostarlimabGSK/
Anaptysbio
516No decision yet
Winlevi
(clascoterone cream 1%)
Cassiopea420Approved
Enspryng (satralizumab)Roche 419Approved
Sogroya
(somapacitan/NN8640)
Novo Nordisk326Approved
Ryoncil (remestemcel-L)Mesoblast274Positive adcom, Pdufa due Sep 30
Olinvyk (IV oliceridine)Trevena226Approved
PedmarkFennec226CRL
RyanodexEagle4CRL
EM-100 (Ketotifen PF Ophthalmic Solution)EtonExtended to Sep 15
VeverimerTricidaCRL
Xaracoll InnocollApproved
TlandoLipocineDelayed, no new action date provided
Lampit (nifurtimox)BayerApproved
Sources: EvaluatePharma, Go or no go? Valuable drugs set for FDA decisions, company releases.
Supplementary and other notable approval decisions in August
ProductCompanyIndication (clinical trial)Outcome
Kesimpta (ofatumumab/Arzerra SC)NovartisRelapsing and remitting MS (Asclepios I and II)Approved 
StelaraBristol Myers/J&JPaediatric patients with moderate to severe plaque psoriasis (Cadmus Jr)Approved 
DovatoGSK/ShionogiHIV-1 infections in virologically suppressed adults (Tango)Approved 
Darzalex (+ Kyprolis + dexamethasone)J&J/GenmabRelapsed/refractory multiple myeloma (Candor)Approved
Trelegy ElliptaGSK/Innoviva/ TheravanceAsthma (Captain)No decision yet
Trelegy ElliptaGSK/Innoviva/ TheravanceCOPD (Impact)Ad com voted 14-1 against mortality benefit claim
XolairNovartisNasal polyps (Polyp 1 and 2)No decision yet
Sources: EvaluatePharma, Go or no go? Valuable drugs set for FDA decisions, company releases.

https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-august

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