European Commission (EC) has decided to reinstate the marketing authorisation for the Roche’s HIV drug, Viracept (nelfinavir)
Roche has regained its Viracept license following the drug's withdrawal from the market in August after a carcinogenic compound was found to have contaminated several drug batches. The EC decision allows the company to recommence manufacture of the drug for distribution in the EU, but Swiss authorities have yet to reinstate the company's license, and several other countries are still deliberating whether to allow the drug back on the market.
Many countries (including those in the Middle East, Far East and some African countries) follow the lead of the Swissmedic agency, and so are still holding back on making the drug available to patients again. There are also further countries that operate independently that are still keeping the drug off the market.
Today's decision gives the company the go ahead to restart manufacturing activities and get the HIV drug back on the market, but given that no patients anywhere in Europe are currently taking the medication, it is unlikely that uptake of Viracept will be particularly high.
Roche altered its manufacturing processes to limit the formation of EMS in the final drug, and has introduced a series of checks during the production process to ensure that the compound can be detected as early as possible. These steps convinced regulators and the EC that the company had taken sufficient steps to warrant the reinstatement of its license, and the return of Viracept to the market.