European Union Medicine Experts Recommend Lifting Temporary Ban on Roche's HIV Drug
September 21, 2007
The European Medicines Agency (EMEA) said Thursday that it backs allowing Roche Holding AG to sell Viracept again, lifting a temporary EU ban. EMEA said the company had corrected manufacturing problems that caused some batches to be contaminated with too much ethyl mesilate, which can damage DNA and possibly trigger cancer.
Roche needs support from the EU's head office, the European Commission, before it can return Viracept (nelfinavir) to the market; the quickest it could do so would be early 2008.
Roche was alerted to the problem in mid-May when six HIV patients noted the drug gave off a strange odor. After tests confirmed contamination, Roche withdrew the drug.
The company tracked the problem to ethanol residues in a holding tank that led to higher doses of ethyl mesilate in batches of Viracept produced near the end of 2006. In June, Roche recalled all Viracept on sale in Europe, including packs patients already had at home. The recall did not affect Viracept usage in the United States, where Pfizer Inc. sells it, or in Canada and Japan.
EU regulators suspended Roche's license to market the drug in August, saying its safety could not be guaranteed until they saw new information from Roche. EMEA said it has now assessed Roche's work to upgrade safety, verified through a factory visit. Roche will no longer use a holding tank and will check for contamination at an early stage in the drug's manufacture. EMEA said Roche has set strict maximum limits for ethyl mesilate; is investigating the harmful effects of ethyl mesilate; and will follow up with patients who were exposed to the contaminated batches.