Summary
Alnylam Pharmaceuticals, Inc. (ALNY) announced a significant event for its flagship product, ONPATTRO® (patisiran). On June 30, 2023, the company disclosed that the U.S. Food and Drug Administration (FDA) has scheduled a Cardiovascular and Renal Drugs Advisory Committee meeting for September 13, 2023. This meeting will focus on the supplemental New Drug Application (sNDA) for ONPATTRO® seeking approval for the treatment of the cardiomyopathy associated with transthyretin-mediated (ATTR) amyloidosis.
Key Highlights
- 1FDA Advisory Committee meeting scheduled for September 13, 2023, to review ONPATTRO® (patisiran) for ATTR-CM.
- 2The meeting concerns a supplemental New Drug Application (sNDA) for ONPATTRO®.
- 3This represents a key regulatory milestone for Alnylam Pharmaceuticals in expanding the label of a major product.
- 4Positive recommendation from the advisory committee could lead to expanded market access for ONPATTRO®.
- 5The news pertains to the treatment of the cardiomyopathy of transthyretin-mediated amyloidosis (ATTR-CM).
Frequently Asked Questions
The FDA Advisory Committee meeting is to review Alnylam's supplemental New Drug Application (sNDA) for ONPATTRO® (patisiran) to potentially treat the cardiomyopathy of transthyretin-mediated amyloidosis (ATTR-CM).
The meeting is scheduled for September 13, 2023.
A positive recommendation from the FDA Advisory Committee would be a significant step towards gaining FDA approval for ONPATTRO® to treat ATTR-CM, potentially expanding its market and revenue.
No, this filing is an announcement regarding the scheduling of a regulatory review meeting. It is not an approval or denial of the sNDA. The information is furnished and not deemed 'filed' for certain SEC liability purposes, meaning it's for informational disclosure and not subject to specific sections of the Exchange Act unless incorporated by reference into a filing.