Roche ‘plans to re-launch Viracept in autumn’

Roche has announced that it plans to re-launch Aids treatment Viracept (nelfinavir), this autumn, in September or October, after the drug had its marketing authorisation suspended by the European commission earlier this week.

This followed a decision by European Medicines Agency to suspend the drug in June after a recall by the company of contaminated batches in the EU.

At the time, Roche had received reports of some batches of the medication emitting an abnormal odour, while analysis showed the tablets to contain unusually high levels of methane sulfonic acid ethylester.

Lifting of the current suspension of marketing authorisation of the drug by the European Commission will have to be preceded by a European Medicines Agency analysis of new data, which Roche anticipates will occur before September or October this year.

Following the original recall, Roche established patient registries for individuals prescribed with Viracept as part of its follow-up measures, while the company also announced additional studies of the effects of methane sulfonic acid ethylester.

William B Burns, chief executive officer of pharmaceuticals at Roche, commented in June that: “We take the welfare of patients extremely seriously.”

He added that the company would follow up on a path of actions agreed in conjunction with the European Medicines Agency.