Amicus Shares Rise After Drug Recommended by EU Regulatory Panelby
Shares of Amicus Therapeutics Inc. jumped after a European regulatory panel recommended its drug for a rare genetic disorder for approval in the European Union. If successful, it will be the biotechnology company’s first product on the market.
The medicine, called migalastat, is a pill for patients with Fabry disease, an inherited disorder marked by the buildup of fat in the body’s cells. The drug was endorsed by a European Medicines Agency panel, the regulator said Friday.
Amicus shares jumped 10 percent to $9.30 at 11:20 a.m. before being halted in New York trading.
Fabry disease causes a host of symptoms including pain, kidney failure and increased risk of heart attack and stroke. It affects about 5,000 to 10,000 people worldwide, according to Cranbury, New Jersey-based Amicus. Migalastat would compete with Fabrazyme, an infused enzyme-replacement therapy for the condition made by Sanofi.
Migalastat hasn’t been approved by the U.S. Food and Drug Administration. In October, Amicus’s plan to file for U.S. clearance was delayed when the agency asked for more data.
The EMA panel’s recommendation is the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation region.