Rhythm May Have Data To Add Indication To Imcivree’s Label
Drug already approved for multiple rare genetic disorders of obesity shows significant weight-loss reduction in Bardet-Beidl syndrome, but not in the smaller indication of Alström syndrome.
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After last month’s news of its proposed acquisition by AstraZeneca, Alexion Pharmaceuticals has bought a priority review voucher from Rhythm Pharmaceuticals, which would speed one of its development projects towards the marketplace.
Keeping Track: Orladeyo, Danyelza, Imcivree Bring CDER 2020 Novel Approval Count Even With Full-Year 2019
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.