NEW YORK — The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.
Pfizer announced that the FDA had accepted its application for tafamidis meglumine, a treatment for transthyretin familial amyloid polyneuropathy. The disease, also known as TTR-FAP, is a fatal genetic illness that affects about 8,000 people worldwide and causes severe sensory loss, pain, weakness and organ dysfunction.
The FDA expected to reach a decision on the drug by June. The European Commission approved the drug in November 2011 under the brand name Vyndaqel.