Return of nelfinavir's European license recommended

Michael Carter
Published: 21 September 2007

European drug regulatory authorities have recommended the lifting of the temporary suspension imposed on the license for nelfinavir (Viracept).

The European Medicines Agency (EMEA) suspended the license for the protease inhibitor in June after it was discovered that batches of the drug had been contaminated with unacceptably high levels of ethyl methanesulfonate (EMS), which has been shown to cause cancer in rats. EMS is used in the manufacture of nelfinavir, but it should be used in such small amounts that it does not pose a risk to health.

Roche recalled all batches of nelfinavir in Europe and most other countries around the world after the contamination was discovered in June. The drug company voluntarily agreed to a temporary suspension of nelfinavir’s license and established patient registries including all HIV-infected adults and children, and nelfinavir exposed but HIV-uninfected infants to see how many people, if any, developed cancer because of exposure to the contaminated nelfinavir.

But in a statement issued on September 20th, the EMEA expressed satisfaction with the “corrective and preventative measures put in place by Roche” after the contamination adding that these measures “have also been verified by inspection of the manufacturing site.”

As a result regulatory authorities are now satisfied that “the cause of the contamination has been eliminated and that future production of Viracept would meet the required quality standards.”

The EMEA’s Committee for Medicinal Products for Human Use has therefore recommended the lifting of the suspension placed on nelfinavir’s license. Once the European Commission has acted on this recommendation, nelfinavir will again be available in the UK.

Although nelfinavir is now rarely used in routine HIV care – at the time it was recalled it is thought that no more than 500 UK patients were taking the drug– it has important “niche” markets, including use for post-exposure prophylaxis.

Nelfinavir was also used during pregnancy, but earlier this month US drug regulatory authorities recommended that pregnant women should no longer take the drug. Nelfinavir in Canada, Japan and the US was unaffected by the recall, but the US Food and Drug Administration has agreed guidelines with the US holder of nelfinavir’s license, Pfizer, to limit patients’ exposure to EMS.

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