Gilead’s Dan O’Day pulls the plug on the lion’s share of their filgotinib collaboration as the FDA erects a high safety barrier. What went wrong?
Five years after Gilead plunked down $725 million in cash to partner with Galapagos on filgotinib, new CEO Dan O’Day has opted to shelve the rheumatoid arthritis program and all but a much smaller piece of the old development plan in the US. The big biotech said Tuesday afternoon that the FDA had erected a high barrier for this drug, which they couldn’t see a way around — or over.
As far as Gilead is concerned, the only commercially viable dose for this drug is 200 mg, and that’s not going to fly at the FDA, where they say regulators made clear in a Type A meeting that they would need to complete “substantial additional clinical studies.” Why? Regulatory concerns over testicular toxicity are running high for this drug, which had aimed to be the fourth JAK inhibitor on the US market.
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