In Surprise Move, FDA Rejects 2 Drugs For Rheumatoid Arthritis, Hemophilia
The unexpected moves against Gilead's filgotinib and BioMarin's Roctavian have rocked the biotech industry, doctors and Wall Street.
An Expected Blockbuster Drug From Gilead Is Rejected, Imperiling Growth
Back before remdesivir became a household name, Gilead Sciences’ most-discussed drug was filgotinib, a treatment for inflammatory disease expected to deliver billions of dollars in new revenue at a time when the biotech desperately needs it. All that got put in jeopardy on Tuesday night. The FDA rejected Gilead’s application to sell filgotinib as a treatment for rheumatoid arthritis and said it wouldn’t reconsider until the company can provide more data on the drug’s effect on patients’ sperm counts. (Feuerstein and Garde, 8/19)
After FDA Rejection Of A Key Drug, Is Gilead Still A Turnaround Story?
The surprise decision by the FDA to reject a Gilead Sciences (GILD) drug for treating inflammatory diseases is clearly a setback for the biotech. The question now, though, is whether Gilead can still be considered a turnaround story that can diversify beyond its core virology business and return to growth levels seen in the past. (Silverman, 8/19)
In A Shocking Decision, FDA Rejects BioMarin’s Gene Therapy For Hemophilia
The Food and Drug Administration on Wednesday rejected a one-time gene therapy for hemophilia A, delaying what would have been a major medical milestone in a decision that upended the expectations of doctors, patients, and Wall Street. The FDA’s move means the gene therapy, which promised to revolutionize the treatment of the bleeding disorder, will be delayed until at least 2022, according to BioMarin, the treatment’s manufacturer. (Garde, 8/19)
FDA Rejection Signals Potential New Hurdles For Gene Therapies
The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder hemophilia has reverberated through the biotech industry, potentially complicating the path to market for these one-time treatments. In deciding not to approve Roctavian, a BioMarin Pharmaceutical gene therapy for hemophilia A, the FDA demanded two additional years of data to strengthen the case that its benefits are durable. (Feuerstein and Garde, 8/20)