ViiV Submits Integrase Inhibitor Dolutegravir for Approval in the U.S., Europe, and Canada

ViiV Healthcare this week announced that it has requested regulatory approval of its investigational integrase inhibitor dolutegravir in several countries. Dolutegravir (formerly known as S/GSK1349572) has demonstrated potent antiviral activity and a good safety profile in both treatment-experienced and previously untreated HIV patients in Phase 3 clinical trials.

Below is an edited excerpt from a ViiV press release describing the regulatory submissions in more detail.

ViiV Healthcare Announces Regulatory Submissions for Dolutegravir in the EU, US and Canada

London, UK -- December 17, 2012 -- ViiV Healthcare today announced the submission of regulatory applications in the European Union (EU), United States (U.S.) and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents, specifically:

• A Marketing Authorization Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
• A New Drug Application to the U.S. Food and Drug Administration for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
• A New Drug Submission to Health Canada for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older. 


"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," said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare. "We are encouraged by the comprehensive data package supporting dolutegravir, and believe that it has the potential to offer an important new option for the treatment of both naive and treatment‐experienced patients with

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.

12/18/12

Source

ViiV Healthcare. ViiV Healthcare Announces Regulatory Submissions for Dolutegravir in the EU, US and Canada. Press release. December 17, 2012.