GSK subsidiary wins FDA approval for new HIV treatment

13th Aug 2013 07:05

ViiV Healthcare, of which pharmaceutical giant GlaxoSmithKline is a large shareholder, has announced that the US Food and Drug Administration (FDA) has approved its new HIV treatment. The product, known as Tivicay, is used in combination with other anti-retroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older. "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," Dr Dominique Limet, the Chief Executive Officer of ViiV Healthcare, said. "This approval shows that our singular focus on HIV can deliver important new medicines, maintaining our absolute commitment to the HIV/AIDS global response." The submission included data from four Phase III clinical trials that treated 2,557 adults (who received at least one dose of study medication) with HIV across the treatment spectrum. Tivicay can be taken with or without food and at any time of the day. "In many regimens, the differentiating component is the third agent. Tivicay provides a new opportunity for healthcare professionals to choose the right regimen for their patients, providing a focal point around which to individualise therapy," added Dr John Pottage, the Chief Medical Officer of ViiV Healthcare. "HIV treatment should not be a 'one-size fits all' paradigm."ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer. NR