Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.

It is estimated that 33.4 million people are living with HIV worldwide, 2.3 million of which are in Europe. Research shows that antiretrovirals have helped to extend life expectancy for people living with HIV. However, new treatments are needed which suppress the replication of the virus while also minimizing the occurrence of unwanted side effects.

The TMC278 filing is based on an extensive global clinical development programme involving more than 1,350 patients in over 20 countries. If approved, TMC278 would help to expand the treatment options for people living with HIV.

"Thanks to advances in treatment, people with HIV are living longer than ever before, which is made possible by continuous research for new and improved treatments," said Eric Lefebvre, Medical Director at Tibotec. "The EMA regulatory submission for TMC278 represents an important part of our ongoing commitment to HIV and to helping patients receive the treatment and care they need."

Pending EMA approval, Tibotec will commercialize TMC278 in the European Union. Tibotec has also submitted new drug applications in the US and Canada, and regulatory submissions for TMC278 in other countries are expected in the coming months. Tibotec has entered into a license and collaboration agreement with Gilead Sciences, Inc. (Nasdaq: GILD) for the development and commercialization of a once-daily fixed-dose combination of TMC278 and Gilead's Truvada(R) (emtricitabine and tenofovir disoproxil (as fumarate)).