EMEA Suspends Viracept Marketing Authorization Over Manufacturing Error

The European Medicines Agency (EMEA) suspended the marketing authorization for Roche’s HIV treatment Viracept after a manufacturing error resulted in a recall of all batches of the product.

As Roche corrects the manufacturing error, the company is in discussions with Pfizer to supply the antiretroviral as one potential option in expediting the product’s return to the market, Roche told MQN. Pfizer manufactures Viracept (nelfinavir) for distribution in the U.S., Canada and Japan, while Roche produces the compound for European Union markets and other countries. Roche originally licensed the product from Agouron Pharmaceuticals, which was later subsumed by Pfizer.

The EMEA has not validated the Pfizer manufacturing site that produces Viracept, Roche said, a necessary step for Pfizer to supply the product for European distribution.

The recall was initiated after Roche received product complaints that some Viracept batches had a strange odor, the company said. Following a chemical analysis, the batches were shown to contain methanesulfonic acid ethyl ester. According to the EMEA, the contaminant is known to cause damage to DNA.

The company told MQN that the root cause of the contamination was related to the cleaning process of a mixing tank used during production. The error resulted in a chemical reaction that created the impurity.

Roche has agreed to establish a registry to follow patients that were exposed to contaminated product. The registry will include all patients exposed to Viracept since March, when contaminated batches were shipped. In addition, the database will include all pregnant women and children ever exposed to the product, including children exposed before birth, the EMEA said.