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” We are dissatisfied in this outcome and will evaluate the points raised in the [complete action letter] for discussion with the FDA,” Merdad Parsey, MD, PhD, Gileads CMO, said in a declaration. “We continue to believe in the benefit/risk profile of filgotinib in RA, which has actually been demonstrated in the FINCH Phase 3 clinical program.”.
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The FDAs rejection produces challenges for Gileads long-lasting vision for the drug. The drugmaker intended to grow filgotinib into a major treatment, with strategies to seek FDA approval for the drug to deal with psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis and eye swelling.
The agency stated it would reconsider its choice just after Gilead can offer more data about filgotinibs impact on users sperm counts. The drugmaker is carrying out 2 research studies to produce that information, however results will not be ready till sometime in 2021.
The FDA turned down Gileads application to offer filgotinib as a rheumatoid arthritis treatment on the evening of Aug. 18, stopping the drugmakers forward-thinking prepare for the treatment it had purported to be a future cash cow.
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Katie Adams –
Wednesday, August 19th, 2020
“We continue to believe in the benefit/risk profile of filgotinib in RA, which has actually been shown in the FINCH Phase 3 scientific program.”.