Boehringer Ingelheim’s Viramune once-daily recommended for EU approval

Boehringer Ingelheim has received a recommendation for approval from the European Medicines Agency (EMA) regarding the once-daily formulation of Viramune (nevirapine), its treatment for the HIV-1 infection.

The EMA's Committee for Medicinal Products for Human Use issued a positive opinion of the drug following clinical trial results that showed a once-a-day formulation of nevirapine had significant therapeutic benefits for patients.

Earlier this year, the once-daily, one tablet 400 mg formulation of Viramune was approved by the Food and Drug Administration in the US.

"Data has shown that the prolonged-release treatment option combines the trusted clinical benefits of nevirapine with the convenience of a single daily dose," explained Professor Klaus Dugi, corporate senior-vice president of medicine at Boehringer Ingelheim.

The recommendation includes the once-daily, one tablet 400 mg strength for adults and adolescents and the once-daily 50 mg and 100 mg strengths for children.

In June, Boehringer Ingelheim received approval from the EMA's medicinal committee for its linagliptin 5 mg film-coated tablets, which will be used to treat adults with type 2 diabetes.