New HIV drug gains EMA approval

Tivicay-Tablets-web ViiV Healthcare, the HIV specialist company formed by GSK and Pfizer, has gained approval from the European Medicines Agency (EMA) for its antiretroviral Tivicay (dolutegravir).

Tivicay has been approved by the EMA for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and adolescents aged 12 and older.

A single-tablet triple combination therapy consisting of Tivicay, Kivexa (abacavir) and Epzicom (lamivudine) was submitted for regulatory approval in Europe in October.

Tivicay is an HIV-1 integrase inhibitor, which blocks replication of the HIV type 1 virus by preventing its DNA from integrating with the DNA of human T-cells – the step that is responsible for establishing chronic infection.

The EMA approval is based on safety and efficacy data from four phase III clinical trials involving more than 2,500 patients, including young people, with comparators representing widely used anti-HIV drugs.

Dr John Pottage, Chief Medical Officer at ViiV Healthcare, said the approval “puts us a step closer to offering this new treatment option to people across Europe who are living with HIV.”

He acknowledged the contribution of patients to the drug’s success: “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.”

Final marketing authorisation from the European Commission is expected to follow in early 2014.

ViiV Healthcare is a global specialist HIV company established in 2009 by GSK and Pfizer. Shionogi joined as a 10% shareholder in 2012. The company aims to lead the field of HIV treatment by delivering new antiretroviral medicines.