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 The leading web portal for pharmacy resources, news, education and careers December 15, 2017
Pharmacy Choice - Pharmaceutical News - Alnylam: FDA Grants Breakthrough Therapy Designation For Patisiran - December 15, 2017

Pharmacy News Article

 11/20/17 - Alnylam: FDA Grants Breakthrough Therapy Designation For Patisiran

WASHINGTON (dpa-AFX) - Alnylam Pharmaceuticals, Inc. (ALNY), a RNAi therapeutics company, announced Monday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation or BTD for patisiran, an investigational RNAi therapeutic targeting transthyretin.

Patisiran is for the treatment of adults with hereditary transthyretin-mediated ATTR amyloidosis or hATTR amyloidosis with polyneuropathy.

BTD is intended to expedite the development and review of drugs for the treatment of serious or life-threatening conditions based on clinical evidence indicating that the drug demonstrates substantial improvement on clinically significant endpoints over available therapy.

Alnylam said it has initiated a rolling New Drug Application for patisiran and expects the last submission by the end of 2017. Patisiran previously received Fast Track Designation in the U.S., and was recently granted accelerated assessment by the European Medicines Agency.

Alnylam, in alliance with Sanofi Genzyme, intends to file a marketing authorization application in the European Union around year-end.

Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world.

Eric Green, Vice President and General Manager of the TTR program, said, "Hereditary ATTR amyloidosis is an aggressive, rapidly progressing, debilitating and fatal disease, and the need for new treatment options is urgent. The robust evidence provided by the APOLLO Phase 3 study demonstrated the potential of investigational patisiran to transform the lives of people with hATTR amyloidosis. Breakthrough Therapy Designation enables us to work closely with the FDA on the review of the NDA to potentially bring patisiran to patients living with this devastating disease as quickly as possible."



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