Roche to establish Viracept patient registries

Swiss drug maker Roche has announced an agreement with the European Agency for the Evaluation of Medicinal Products (EMEA) which will see it establish registries to monitor patients that have been exposed to chemical impurity.

The Basel-based group’s licence for its HIV formulation Viracept has been suspended pending a review by health authorities following the discovery of ethyl methansulphonate (EMS).

Roche recalled all formulations of Viracept on June 6th and its announcement to establish registries for patients being treated with the drug are part of follow-up measures.

“We take the welfare of patients extremely seriously. With the knowledge we have to date, we consider the risk to patients to be low, however, we want to be sure patients can be followed and these registries will allow us to do just that ,” said William Burns, chief executive of Roche’s pharmaceuticals division.

“The root cause of the elevated levels of impurity observed recently has been identified and we are following up on the agreed actions with EMEA,” he added.

Viracept’s European licence has been suspended, though markets in the US, Canada and Japan have not been affected.

The drug is an anti-retroviral protease inhibitor marked in Europe by Roche for the treatment of HIV.