BioCentury
ARTICLE | Clinical News

Caelyx regulatory update

March 26, 2012 7:00 AM UTC

EMA recommended that the manufacturing process for cancer drugs Caelyx doxorubicin from Johnson & Johnson and Ceplene histamine dihydrochloride from EpiCept be transferred to alternative facilities from the Ben Venue Laboratories Inc. facility. EMA's CHMP recommended that the MAAs be maintained during the transfer because the drugs are "essential for patients" and no alternatives are available. According to the agency, Ben Venue is the only site that manufactures the drugs for the EU. EMA expects to complete the transfer of the manufacturing process for Ceplene and Caelyx by year end 2013 and 2014, respectively. In February, 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 (see BioCentury, Feb. 27).

The agency also reiterated that Caelyx from Ben Venue should only be used to complete treatment in patients that already started treatment and no new patients should be started on the drug until the sterile filtration and aseptic filling process has been transferred to a new manufacturing site. Last year, CHMP said no new patients should be treated with Caelyx after identifying the GMP shortcomings. J&J markets doxorubicin as Doxil in the U.S. and elsewhere as Caelyx (see BioCentury, Dec. 5, 2011). ...