Amgen seeks FDA review of Tavneos to determine continued market availability
read at Endpoints ↗RegulatoryNeutral
Amgen has formally asked the U.S. Food and Drug Administration to re-examine the data supporting its drug Tavneos (avacopan).
Tavneos is indicated for a rare form of vasculitis and the request signals that its market status is under review.
The outcome of the FDA review will determine whether the drug remains available to patients, creating uncertainty for those relying on it.
source
This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “Amgen and the FDA want two different outcomes for Tavneos. What will patients do?”
read at Endpoints ↗83 words · retrieved Jun 12
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