Gilead's Filgotinib, a Collaboration With Galapagos, Gets Complete Response Letter for Application From FDA
August 18 2020 - 8:20PM
Dow Jones News
By Josh Beckerman
Gilead Sciences Inc. said the Food and Drug Administration
issued a complete response letter for its New Drug Application for
rheumatoid arthritis drug filgotinib.
The FDA requested data from the MANTA and MANTA-RAy studies,
which are designed to assess whether filgotinib has an impact on
sperm parameters, Gilead said. The company said it is
"disappointed."
The agency also expressed concerns regarding the overall
benefit/risk profile of the 200-milligram dose.
The FDA says it will send an applicant a complete response
letter if the agency determines it won't approve an application or
abbreviated application in its present form.
Gilead and Galapagos NV are collaborating on filgotinib in
rheumatoid arthritis and other inflammatory indications. Galapagos
said it is revising its cash burn guidance, as prior guidance
included an expected $100 million approval milestone.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
August 18, 2020 20:05 ET (00:05 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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