Angiox regulatory update
EMA's CHMP issued final recommendations on a Good Manufacturing Practice Certificate issued to Ben Venue Laboratories Inc. preventing the third-party manufacturer from supplying 12 non-essential drugs. CHMP recommended removing Ben Venue's manufacturing site from the MAAs for Angiox bivalirudin, Busilvex busulfan, Ecalta anidulafungin, Cayston aztreonam, Mepact mifamurtide, Soliris eculizumab, Torisel temsirolimus, Velcade bortezomib, Vidaza azacitidine, and Vistide cidofovir. The agency said alternative manufacturers are available for all 10 drugs. CHMP also recommended suspending the MAAs for the 2 other drugs, Vibativ telavancin and Luminity perflutren, which are not currently marketed in the EU and for which there is no other manufacturer. The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) issued the GMP certificate last month.
The agency said a review of 2 other cancer drugs, Caelyx pegylated liposomal doxorubicin from Johnson & Johnson and Ceplene histamine dihydrochloride from EpiCept, is expected to be completed next month. CHMP noted that Gilead, which markets antiviral drug Vistide and cystic fibrosis drug Cayston, has already removed the site from MAA for both drugs. Ben Venue is a subsidiary of Boehringer Ingelheim GmbH (Ingelheim, Germany). ...