Home » FDA Delays Decision on Anylam’s Amyloidosis Drug
FDA Delays Decision on Anylam’s Amyloidosis Drug
The FDA has pushed back by three months its decision on Anylam Pharmaceuticals’ New Drug Application (NDA) for its investigational drug vutrisiran for patients with transthyretin-mediated amyloidosis.
The agency needs more time to review information from the company’s new secondary packaging and labeling facility. The FDA recently inspected a previous packaging and labeling facility, which led to the company looking for a new facility, Anylam said.
The company also said that the agency did not ask for any additional data. The FDA decision on the NDA is now slated for July 14.
The investigational drug is also under review by the European Medicines Agency.
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