European Commission Lifts Suspension On Sale Of Roche's Antiretroviral Viracept

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 22 Oct 2007 - 7:00 PDT

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The European Commission has restored pharmaceutical company Roche's license to market its antiretroviral drug Viracept in the European Union, the company announced on Friday, AFP/EU Business reports (AFP/EU Business, 10/19). The European Medicines Agency 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. EMA last month recommended lifting the ban.

Before making the recommendation, 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. To prevent harmful chemical interactions, Roche will no longer use a vessel in production of the drug. 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 recommended that Roche monitor people who were exposed to contaminated lots of Viracept, including pregnant women and children who were ever exposed to the drug. Roche agreed to continue investigation into harmful side effects of the substance and to follow up with patients (Kaiser Daily HIV/AIDS Report, 9/24).

William Burns, CEO of Roche's pharmaceutical division, said the company is "pleased" with the decision, adding, "Our teams have worked diligently in manufacturing and in close collaboration with the health authorities, health care providers, [nongovernmental organizations], treatment providers and patient groups on the recall with the full intention of re-supplying this medication." According to Roche, the timing of Viracept's availability will differ among E.U. member countries, and it likely will be a few months before the drug fully is available to doctors and those previously taking it (Roche release, 10/19).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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