Alnylam Drops Label-Expansion Effort For Onpattro After FDA Complete Response

 
• By Joseph Haas
  
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Giving up on adding a cardiomyopathy indication to Onpattro’s label, Alnylam now will focus on adding that disease to Amvuttra’s label. Onpattro got a thumbs-up from an FDA advisory panel in September.

Change of plan
Alnylam has revised its plans in cardiomyopathy following an FDA rejection • Source: Shutterstock

Alnylam Pharmaceuticals Inc. got a reminder of the necessity of following US Food and Drug Administration guidance on 9 October when it received a complete response letter for its supplemental new drug application seeking to add an ATTR cardiomyopathy indication to Onpattro’s label.

Key Takeaways

  • The FDA issued a CRL for Alnylam’s application to expand Onpattro’s label into ATTR cardiomyopathy despite a 9-3 vote by an advisory panel for the drug’s risk/benefit profile.

During a same-day investor call, Alnylam CEO Yvonne Greenstreet said she was “extremely disappointed” by the FDA’s decision, but a...

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