Health
Ipsen Gets FDA Advisers’ Backing for Rare Bone Disease Drug
- Ipsen shares rise on improved prospect for US approval
- FDA had asked drugmaker for additional data last year
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Ipsen SA’s drug for a rare bone disease got support from a panel of US drug regulatory advisers, moving the first treatment for the condition closer to approval.
Advisers to the Food and Drug Administration voted 11-3 Wednesday that the benefits of the treatment, palovarotene, outweigh its risks. The FDA isn’t required to follow the recommendations of its advisers, but frequently does.