ViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents. A priority review designation is granted to drugs that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The FDA has assigned dolutegravir a Prescription Drug User Fee Act (PDUFA) target date of 17 August, 2013.
The new drug application (NDA) for dolutegravir was received by the FDA on 17 December 2012, and includes the results of four pivotal phase III clinical trials that treated a total of 2553 patients with HIV/AIDS across the treatment spectrum, from therapy naïve to salvage patients. Dolutegravir is in development and subject to evaluation of the benefits and risks by the regulatory authorities before it can be approved and made available on prescription.
ViiV Healthcare submitted a Marketing Authorisation Application (MAA) for dolutegravir to the European Medicines Agency (EMA) on 17 December, 2012.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.