Safety threat forces FDA to put a hold on Regeneron, Teva’s big NGF pain drug fasinumab
Just one month after Teva agreed to pay Regeneron $250 million in cash to partner on its NGF pain program, the FDA has slapped a clinical hold on their Phase IIb study of fasinumab for lower back pain.
The hold was triggered after a patient in the study suffering from advanced osteoarthritis developed a case of adjudicated arthropathy – joint disease. And the new partners are countering the hold by planning to exclude osteoarthritis patients from a planned Phase III.
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