Johnson and Johnson HIV drug gets EU marketing authorisation

Tibotec Pharmaceuticals, a member of the Johnson & Johnson family of companies, has announced that Intelence (etravirine) has received marketing authorisation in the European Union (EU) as a combination therapy for HIV.

The company said the compound is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in patients with a virus resistant to NNRTIs.

It noted the drug is the first new NNRTI to be introduced for around a decade.

Intelence was developed by Tibotec Pharmacueticals and will be marketed in Europe by Tibotec, a division of Janssen-Cilag.

The compound is indicated for the treatment of HIV infection in antiretroviral treatment-experienced adult patients in combination with other antiretroviral products and a boosted protease inhibitor.

Professor Christine Katlama, head of the Aids Clinical Research Unit in the Department of Infectious Diseases at Pitie-Salpetriere Hospital in Paris, France, said: “NNRTIs have been trusted by physicians and used in antiretroviral therapy for more than a decade, but NNRTI resistance has limited the use of this important class of HIV medication.”

She added that Intelence expands the NNRTI class to thousands of treatment-experienced patients in Europe to offer them the potential to suppress the virus in their bloodstream to undetectable levels.

In February 2008, Johnson & Johnson announced the publication of 48-week efficacy and safety data for Intelence as part of an HIV combination therapy.