Generic Version of HIV Drug Recommended for EU

The European Medicines Agency (EMA) has given a positive opinion to a generic medicine, emtricitabine/tenofovir alafenamide, for the treatment of adults and adolescents infected with HIV type 1 (HIV-1). 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) said that the combination is a generic of the branded medicine Descovy, which has been authorized in the EU since April 21, 2016. The two active substances are antivirals that exert their effects by inhibiting HIV reverse transcriptase through incorporation into the viral DNA, resulting in chain termination. 

Studies have demonstrated the satisfactory quality of emtricitabine/tenofovir alafenamide, CHMP said, and its bioequivalence to the reference product Descovy. Like Descovy, emtricitabine/tenofovir alafenamide is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents aged 12 years or older with body weight at least 35 kg, who are infected with HIV-1. 

The drug is an oral medication available as 200 mg/25 mg and 200 mg/10 mg film-coated tablets to be taken once daily. The most common side effects include nausea, diarrhea, headache, dizziness, depression, fatigue, insomnia, strange dreams, stomach pain, weight loss, and rash.

Therapy should be initiated by a physician experienced in the management of HIV infection.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.