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 Tivicay® (dolutegravir) for use in combination with other antiretroviral medicinal products for the treatment of HIV-infected adults and adolescents above 12 years of age.
“We welcome the CHMP’s positive opinion on dolutegravir – it puts us a step closer to offering this new treatment option to people across Europe who are living with HIV,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “We are committed to research that seeks to make advances in treatment options for people living with HIV. To make progress, thousands of patients have supported us through their participation in clinical development work and we recognise their commitment today with great gratitude.”
The CHMP opinion is based on safety and efficacy data for dolutegravir from four pivotal Phase III studies.(1-4) These involved people living with HIV who were new to treatment and also those with prior experience of treatment, and included comparators representing antiretroviral treatments commonly used today in the battle against HIV. More than 2,500 people were treated across these studies, and the regulatory submission also included data in children aged 12 years and older.
A CHMP positive opinion is one of the final steps in the regulatory process leading to the marketing authorisation decision of the European Commission, which is expected early in 2014.
About Tivicay® (dolutegravir)
Tivicay® was approved by the U.S. FDA in August 2013 and by Health Canada in October 2013 – please refer to local labelling for more information. It is a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Regulatory applications are being evaluated in other countries worldwide. Regulatory applications for ViiV Healthcare’s developmental single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the US in October 2013.
- SINGLE (Study ING114467). A Trial Comparing GSK1349572 (dolutegravir) 50mg Plus Abacavir/Lamivudine Once Daily to Atripla. National Institutes of Health Study Identifier NCT01263015. More information available at:http://www.clinicaltrials.gov/show/NCT01263015
- SPRING-2 (Study ING113086). A Trial Comparing GSK1349572 (dolutegravir) 50mg Once Daily to Raltegravir 400mg Twice Daily. National Institutes of Health Study Identifier NCT01227824. More information available at:http://clinicaltrials.gov/show/NCT01227824
- VIKING-3 (Study ING112574). A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. National Institutes of Health Study Identifier NCT01328041. More information available at: http://clinicaltrials.gov/show/NCT01328041
- SAILING (Study ING111762). A Study of GSK1349572 (dolutegravir) Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults. National Institutes of Health Study Identifier NCT01231516. More information available at: http://clinicaltrials.gov/show/NCT01231516