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news.Tibotec Pharmaceuticals, a pharmaceutical research and development company, has announced that the European Medicines Agency has granted marketing authorization for the anti-HIV medication Intelence.
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Intelence is said to be the first new non-nucleoside reverse transcriptase inhibitor to be introduced in approximately 10 years. Also known as TMC125, Intelence will be marketed in Europe by Tibotec, a division of Janssen-Cilag. Janssen-Cilag International will hold the marketing authorization.
The European Medicines Agency decision follows similar approvals earlier in the year in Switzerland, Russia, Argentina, Canada, South Korea and the US. Commercial launches will vary from country to country, based on local price and reimbursement discussions with national authorities.
Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
Roger Pomerantz, president of R&D at Tibotec, said: “The approval of Intelence demonstrates our ongoing commitment to providing innovative therapies for treatment-experienced HIV patients. We are committed to working with national health authorities to quickly make this drug available to people living with HIV in Europe who need new treatment options.”