A new AIDS drug may soon be on its way to market.

ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer and Shionogi, filed for regulatory approval of its proposed treatment for HIV on Monday in the U.S., Canada and the European Union.

Boosted by recent test results, ViiV is seeking to advance an investigational integrase inhibitor called dolutegravir. It would be used to treat adults and adolescents fighting the AIDS virus. 

The experimental treatment  reduced the virus in hard-to-treat patients in a late-stage study reported in September, providing further support for the regulatory filing.

After 24 weeks on dolutegravir, 63 percent of 183 participants who had shown resistance to previous treatments had undetectable levels of the virus.

The study is the third of four late-stage trials to be reported this year that ViiV planned to use in filing for regulatory clearance of dolutegravir.

If approved, dolutegravir would be the second, behind Merck & Co.’s raltegravir, in a new class of HIV medicines called integrase inhibitors that work by blocking the virus’s ability to replicate.

The applications filed:

  • A Marketing Authorisation 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 US 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 for ViiV Healthcare, in a statement.

“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 naïve and treatment-experienced patients with HIV.”

GSK (NYSE: GSK) and Pfizer (NYSE: PFE) formed the joint venture in November 2009. Shionogi became an investor in October.

GSK operates its North American headquarters in RTP.

[GSK ARCHIVE: Check out 10 years of GSK stories as reported in WRAL Tech Wire.]