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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Jun 14, 2022)

Filed June 14, 2022For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) announced a significant development on June 13, 2022, with the U.S. Food and Drug Administration (FDA) approval of its new drug application for AMVUTTRA™ (vutrisiran). This RNAi therapeutic is indicated for the treatment of the polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients. AMVUTTRA™ offers a subcutaneous injection administered quarterly, providing a convenient treatment option for patients suffering from this rare and progressive disease. The approval of AMVUTTRA™ represents a key milestone for Alnylam, expanding its portfolio of RNAi therapeutics and addressing an unmet medical need in hATTR amyloidosis. This new indication is expected to contribute to the company's revenue growth and solidify its position as a leader in the development of genetic medicines. Investors should monitor the commercial launch and uptake of AMVUTTRA™ as it becomes available to patients.

Key Highlights

  • 1FDA approval of AMVUTTRA™ (vutrisiran) for the treatment of hATTR amyloidosis polyneuropathy in adults.
  • 2AMVUTTRA™ is an RNAi therapeutic administered via subcutaneous injection.
  • 3The drug is dosed once every three months (quarterly), offering a convenient administration schedule.
  • 4This approval addresses a significant unmet medical need in patients with hereditary transthyretin-mediated amyloidosis.
  • 5The announcement was made via a press release filed as an exhibit to the 8-K.
  • 6This marks an expansion of Alnylam's RNAi therapeutic portfolio.

Frequently Asked Questions

AMVUTTRA™ (vutrisiran) is approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients.

AMVUTTRA™ is administered via a subcutaneous injection, meaning it is injected just under the skin.

AMVUTTRA™ is administered once every three months, or quarterly.

hATTR amyloidosis is a rare, progressive, and debilitating genetic disease caused by mutations in the transthyretin (TTR) gene. These mutations lead to the misfolding and aggregation of TTR protein, forming amyloid deposits in various organs, including nerves and the heart, leading to polyneuropathy and cardiomyopathy.