ViiV Healthcare announces FDA priority review for HIV infection treatment

ViiV Healthcare has announced the US Food and Drug Administration (FDA) has granted a priority review designation to dolutegravir for the treatment of HIV.

A priority review designation is granted to drugs that have the potential to provide significant improvement in comparison to marketed products or offer a treatment where there is no adequate therapy.

Dolutegravir has been assigned a Prescription Drug User Fee Act (PDUFA) target date of 17th August.

This new application was obtained by the FDA on December 17th and includes the results of four phase III clinical trials, treating a total of 2553 patients with HIV/AIDS across the treatment spectrum, ranging from therapy naïve to salvage patients.

Dolutegravir is in development and will be subjected to evaluation from regulatory authorities before it can be approved and made available in the pharma industry.

ViiV Healthcare is a worldwide specialist HIV company that was established in November 2009 by GlaxoSmithKline and Pfizer and is dedicated to providing advances in treatment and care for people living with the disease.

It aims to take a broader interest in HIV/AIDs than any other company, delivering a new approach to provide new medicines and support communities which have been impacted by the condition,

In December, ViiV Healthcare announced the submission of regulatory applications in the European Union, United States and Canada for dolutegravir.

John Pottage, MD, chief scientific and medical officer, ViiV Healthcare, said: "These regulatory submissions are an important step for ViiV Healthcare, representing our commitment as a company to bring new treatments to people living with HIV.

"We are encouraged by the comprehensive data package supporting dolutegravir, and believe it has the potential to offer an important new option for the treatment of both naïve and treatment-experienced patients with HIV."

Posted by Neil Clark