A panel of European Medicines Agency recommended approval for GlaxoSmithKline’s two-drug regimen to treat HIV, the virus that causes AIDS.
The combination was approved by the U.S. Food and Drug Administration in November. The CHMP opinion sets the stage for a likely approval by the European Commission, which is expected toward the end of the second quarter of 2018, GSK said in a statement.
The new HIV treatment, Juluca, is a fixed-dose once-daily tablet that combines two previously approved drugs, dolutegravir, and rilpivirine, and is available to patients who have been on a stable regimen for at least six months.
Juluca is produced by GSK’s majority-owned ViiV Healthcare, in which Pfizer and Shionogi also have small stakes.
ViiV’s integrase inhibitor drug dolutegravir is part of GSK’s traditional triple-therapy used to control HIV, while rilpivirine is a Johnson & Johnson drug.
(Reporting By Justin George Varghese in Bengaluru; Editing by Arun Koyyur)