European Medicines Agency Recommends That Ban on Sale of Roche’s Antiretroviral Viracept Be Lifted
The European Medicines Agency on Thursday recommended lifting a temporary European Union ban on the sale of Roche's antiretroviral drug Viracept, the AP/Forbes reports (AP/Forbes, 9/20).
EMA in June recalled Viracept because of contamination with the substance ethyl mesilate -- which can damage DNA and lead to cancer -- in certain lots of the drug. Roche in a statement said that it recalled all batches of the drug in Europe and other undisclosed countries in cooperation with EMA and Swissmedic, Switzerland's drug regulator. The European Commission in August suspended Roche's license to market Viracept in the European Union.
According to the European Commission, the suspension was based on scientific conclusions from EMA and consultations with members of the European Union. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester -- a chemical normally used in the drug in small quantities. William Burns, CEO of Roche's pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. The European Commission last month suspended Roche's license to market Viracept (Kaiser Daily HIV/AIDS Report, 8/8).
EMA Comments
EMA officials visited the Roche factory where Viracept is manufactured to assess the company's efforts to improve safety and found that the manufacturing problems had been solved, the AP/Forbes reports. Roche will no longer use a vessel in production of the drug to prevent harmful chemical interactions. In addition, Roche will check for contamination at early stages in the drug's production and has set maximum limits for ethyl mesilate.
EMA officials also asked Roche to continue research to determine how much ethyl mesilate is toxic for humans. In addition, EMA also recommended that Roche monitor people who were exposed to contaminated lots of Viracept, as well as pregnant women and children ever exposed to the drug. Roche agreed to continue investigation into harmful side effects of the substance and to follow up with patients.
EMA officials said that the agency "has been reassured that the cause of the contamination has been eliminated and that future production of Viracept would meet the required quality standards." The European Commission will have to approve the proposed lifting of the ban before Roche can begin selling the drug. The commission said that early 2008 is the soonest it will make a decision (AP/Forbes, 9/20).
