ViiV Healthcare’s first investigational once-daily single-tablet regimen, combining the integrase inhibitor dolutegravir and nucleoside analogues abacavir/lamivudine.
ViiV Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine) for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg.
"Today's positive opinion takes us a step closer to bringing physicians and people living with HIV a dolutegravir based regimen that can be taken once-daily as a single-tablet," said Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "This opinion supports the potential of dolutegravir based regimens, as well as the importance of our ongoing research into additional single-tablet treatment options.”
The CHMP positive opinion is based upon data from two pivotal studies:
the Phase III study of dolutegravir (SINGLE),conducted with dolutegravir and abacavir/lamivudine as separate pills1
a separate bioequivalence study of the fixed-dose combination of dolutegravir/abacavir/lamivudine when taken as a single tablet compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.2
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), but does not always result in marketing authorisation. A final decision by the EC is anticipated during the third quarter of 2014.
Triumeq (dolutegravir/abacavir/lamivudine) is not currently approved in any country and is an investigational once-daily single tablet dolutegravir based regimen, containing the integrase inhibitor dolutegravir which was approved by the EMA in January 2014 under the brand name Tivicay®.
A New Drug Application (NDA) for abacavir/dolutegravir/lamivudine was submitted to the U.S. Food and Drug Administration (FDA) in October 2013, and is currently under review. The regulatory submission and review processes have also been initiated in Canada, Australia, Brazil and Japan.
Important Safety Information forTivicay (dolutegravir) and Kivexa (abacavir/lamivudine) in the European Union: Please refer to the full European Summary of Product Characteristics for full prescribing information for dolutegravir and abacavir/lamivudine.
Kivexa®, Tivicay and Triumeq are registered trademarks of the ViiV Healthcare group of companies. The use of the brand name TRIUMEQ is not approved by any regulatory authorities.
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.
1. Walmsley SL, Antela A, Clumeck N et al; for the SINGLE Investigators. Dolutegravir plus abacavir–lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807-1818.
GlaxoSmithKline cautionary statement regarding forward-looking statements: GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.