Roche announced that the European Medicines Agency’s (EMEA) Committee for Human Medicinal Products (CHMP) has recommended that Viracept’s marketing authorization is re-instated in Europe following its suspension earlier this summer.
The Committee stated that it is satisfied with the actions taken by Roche. The positive recommendation is an important step towards lifting the suspension of the marketing authorization and will now go to the EU Commission for a final decision.
Roche fully intends to re-supply Viracept (nelfinavir) once the suspension is lifted. However, it may take a few months for Viracept to be available again to prescribers and patients.
Viracept’s license was suspended in August this year following the discovery that some of the drug batches contained a substance called ethyl mesylate (EMS).
“From the beginning of the recall, Roche acted responsibly, quickly and always in the best interests of patients. In a situation such as this, the most prudent action was to recall the medication” said William M. Burns, CEO of Roche’s Pharmaceutical Division “We have worked tirelessly with the health authorities, physicians, health care providers, NGO treatment providers and, of course, patient groups on the recall with the full intention of re-supplying this medication.”
The Viracept recall affects those countries where Roche-made Viracept is sold or distributed. This excludes the US, Canada and Japan where Pfizer has the responsibility to make and distribute Viracept.