Janssen-Cilag reports positive opinion on Prezista

Tibotec, a division of Janssen-Cilag, has reported that the Committee for Medicinal Products for Human Use (CHMP) has issues a positive opinion recommending approval of its HIV treatment Prezista (darunavir).

Prezista is indicated in conjunction with other antiretrovirals for the treatment of HIV-1 infection in adults that have failed treatment with more than one course including a protease inhibitor. The company expects marketing authorisation from the European Commission for the compound in early 2007.

Julie McHugh, company group chair of Tibotec, commented that the company “strongly” welcomed the opinion issued by the CHMP.

“We will continue to work closely with the European regulatory authorities to ensure Prezista becomes available as an important option for the increasing number of people in Europe with HIV who have been treated with more than one protease inhibitor.

The compound is currently already authorised for use in the US, Canada, Russia and Switzerland.

Tibotec aims to deliver novel HIV and Aids products to patients in the Middle East, Europe and Africa. It was founded in October 2005 to focus on the treatment of this disease and aims to be involved in the commercialisation of pharmaceutical products for other viral infections.

Last week, Tivotec announced the results of a clinical trial of Telaprevir, an investigational HCV protease inhibitor.