Questions and answers on the CHMP recommendation to allow Viracept back onto the market
News
20/09/2007 - In August 2007, the marketing authorisation for Viracept was suspended because of contamination of the medicine due to a problem in its manufacture. Having looked at the measures put in place by the manufacturer, Roche, the European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP) has now made a recommendation to the European Commission (EC) that the suspension be lifted and Viracept be allowed back onto the market.
What is Viracept?
Viracept is an antiviral medicine, which contains nelfinavir (as nelfinavir mesilate) as its active substance. It is available as tablets and as a powder to be made up into an oral suspension. It is used in combination with other antiviral medicines to treat adults, adolescents and children over three years of age who are infected with human immunodeficiency virus (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS).
What has been happening with Viracept?
During the last few months of 2006 and at the beginning of 2007, some batches of nelfinavir mesilate became contaminated with high levels of ethyl mesilate, a known genotoxic substance (harmful to DNA, the genetic material in cells). The contaminated batches were used to make Viracept for all markets, except those in Canada, Japan and the United States. This led to Viracept contaminated with high levels of ethyl mesilate reaching the market from March 2007. The contamination was first noticed by some patients because the tablets had a strange smell.
Because ethyl mesilate is a harmful substance, Viracept was removed from the market (recalled) at the beginning of June, and doctors had to switch their patients to an alternative treatment. Since the recall of the medicine, Roche has begun to set up registries in order to follow up patients who were exposed to the highly contaminated batches of the medicine. The company will also follow up children who have taken the medicine, and children born to mothers who took Viracept during pregnancy. Roche also temporarily stopped the production of nelfinavir mesilate.
The company was asked to look in depth into the reason for the contamination, in order to find out why it happened, and to ensure that appropriate measures could be put in place to make sure that it would not happen again. While this was underway, the EC, on the recommendation of the CHMP and the EMEA, decided to suspend Viracept's marketing authorisation. This suspension came into force on 6 August 2007.
Why is the suspension being lifted?
At its September 2007 meeting, the CHMP assessed the answers given by Roche to the Committee's questions, and looked at the report from the inspectors who visited the factory in Switzerland where nelfinavir mesilate is made. The Committee was satisfied by the actions taken by the company, and by the outcome of the inspection, which confirmed that the necessary measures had been put in place.