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Anders bekeken:Gilead firms up path to market for key arthritis drug
By Ned Pagliarulo
Published July 2, 2019
Dive Brief:
Gilead said Tuesday it plans to submit its experimental arthritis treatment filgotinib for U.S. approval this year, a speedier-than-expected timeline that could shorten the lead held by rival AbbVie for a competing drug.
Filgotinib, one of a class of drugs known as JAK inhibitors, proved effective in treating rheumatoid arthritis in two Phase 3 studies that read out results earlier this year. A slow-enrolling male toxicity study required by the Food and Drug Administration, however, had looked set to delay an application from Gilead for filgotinib's approval.
Now, after discussions with the FDA, Gilead intends to submit the drug this year, having established "a path forward" with the regulator. The change in plans is important, as analysts consider
filgotinib to be
Gilead's most important pipeline product.
Dive Insight:
A
filing this year for filgotinib could set up a potential market launch in 2020, which would be one to
two years earlier than some on Wall Street had been anticipating.Net wat Onno zei op 2 juli 2019
FDA heeft genoeg data voor groen licht.
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