Glybera alipogene tiparvovec regulatory update

EMA's CHMP issued a third negative opinion against approval of Glybera to treat lipoprotein lipase (LPL) deficiency. CHMP issued the opinion as a response to a request for more information on Glybera's profile from the European Commission, which could not reach a final decision on the MAA at a January meeting (see BioCentury, Feb. 3 & Feb. 27). Glybera is an adeno-associated virus (AAV) vector encoding LPL gene. ...