ViiV Healthcare Announces the designation of priority review for dolutegravir as a potential treatment for HIV infection.
London, United Kingdom, February 2013.- ViiV Healthcare has announced that the. Food and Drug Administration (FDA) of the United States has granted the designation of priority review to dolutegravir for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents. The priority review designation is assigned to which, if adopted, have the potential to provide a significant benefit compared to marketed drugs or drugs that provides a treatment where there is no adequate therapies. The FDA has set the deadline to complete the review of dolutegravir on August 17, 2013, within the program Prescription Drug User Fee Act (PDUFA).
As dolutegravir new drug application was submitted to the FDA on December 17, 2012, and includes the results of four clinical pivotal trials in which a total of 2.553 patients have been treated with HIV/AIDS in all stages of treatment, from patients who have not received anti-retroviral treatment to patients in failure. Dolutegravir is in development and subject to the evaluation of their benefits and risks by regulators before it can be approved and may be available for prescription.
ViiV Healthcare submitted a marketing authorization application for dolutegravir at the European Medicines Agency (EMA) on 17 December of 2012.
About ViiV Healthcare
ViiV Healthcare is a global company specializing in HIV created in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to yield breakthroughs in the treatment and care of people living with HIV. The aim of the company is showing an interest in more extensive and profound HIV any other company had previously and make a new approach to the effective development of new drugs for HIV, as well as support for the communities affected by HIV.
