Alnylam Pharmaceuticals, Inc. ALNY announced that the European Commission (EC) has granted marketing authorization for Onpattro (patisiran), the first ever RNA interference (RNAi) therapeutic, for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The European Medicines Agency reviewed patisiran under the accelerated assessment procedure.
The European approval of Onpattro was based on the results from the APOLLO study that met its primary as well as all secondary endpoints
hATTR amyloidosis is a rare, inherited, rapidly progressive and life-threatening disease. The approval of Onpattro marks the arrival of a first-of-its kind treatment option for a rare and devastating disease with limited treatment options. The approval also represents an entirely new approach to treating patients with polyneuropathy in hATTR amyloidosis.
Onpattro was approved by the FDA in the United States in August. The drug is the first and only FDA approved therapy for the treatment of the polyneuropathy of hATTR amyloidosis in adults.
Onpattro, which is the first approved drug in Alnylam`s portfolio, is expected to be drive revenue for the company.
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