ViiV Healthcare’s HIV drug granted FDA priority review
GSK and Pfizer’s specialist global HIV company, ViiV Healthcare, has announced that the US 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 includes the results of four pivotal phase 3 clinical trials that treated a total of 2553 patients with HIV / AIDS across the treatment spectrum.
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.
The company has also submitted a Marketing Authorisation Application (MAA) for dolutegravir to the European regulatory body, European Medicines Agency (EMA), on 17 December, 2012.
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