Glybera alipogene tiparvovec regulatory update

Amsterdam Molecular said it received a request from EMA's CHMP for additional information on Glybera to treat lipoprotein lipase (LPL) deficiency by March 8. The committee indicated a final decision on Glybera could be made by May. Last month, the European Commission asked for more information from the committee before making a final decision on an MAA for the adeno-associated virus (AAV) vector encoding LPL gene. According to the company, the EC could not reach a decision at a Jan. 22 meeting on the application, noting a member state formally objected. EMA's CHMP issued an initial negative opinion in June 2011. The committee then reexamined the opinion and issued a second negative opinion in October (see BioCentury, Feb. 6).

Amsterdam Molecular discontinued development of Glybera after the second negative opinion (see BioCentury, Oct. 31, 2011). At the time, the company said that in the event Glybera could be marketed in Europe, it would need to review its business strategy and determine how to commercialize the product. ...