ViiV Healthcare’s new HIV drug wins US FDA approval

A new drug to treat HIV-1 infection has been approved by the US Food and Drug Administration. Tivicay (dolutegravir) is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

Tivicay is ViiV Healthcare's first new treatment. The global specialist HIV Company was established in November 2009 by GSK and Pfizer.

"Today is a very important milestone for patients and the scientists and teams who developed Tivicay and brought it to this point of FDA approval. I am very proud that we are serving people living with HIV with a much-needed new treatment option. Today's approval shows that our singular focus on HIV can deliver important new medicines, maintaining our absolute commitment to the HIV / AIDS global response,"

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.

Tivicay has been approved for use in a broad population of HIV-infection patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors.

The HIV drug is also approved for children ages 12 years and older weighing at least 40 kg who are treatment-naïve or treatment-experienced, but have not previously taken other integrase strand transfer inhibitors.

"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs. The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Approximately 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention.

Viiv Healthcare has also submitted a Marketing Authorization Application for dolutegravir to the European Medicines Agency (EMA) and regulatory applications are also being evaluated in other markets worldwide, including Canada and Australia.