The European Commission has approved Boehringer Ingelheim’s update of Viramune (nevirapine) for the treatment of patients with HIV.
The EU commission approved an update of the Summary of Product Characteristics (SPC) for Viramune, which reflect clinical studies demonstrating that nevirapine has been associated with an increase in HDL cholesterol and an overall improvement in the total HDL cholesterol ratio.
Boehringer Ingelheim senior vice-president of medicine Dr Manfred Haehl said that the company was pleased that Viramune’s positive impact on lipids had been recognised by the European Commission.
“Cardiovascular disease has become an increasing cause of morbidity and mortality in patients with HIV. Physicians treating patients with HIV need to have a range of treatment options available so they can tailor the therapy to the individual patient’s need and response,” Haehl said.
“We are further exploring Viramune’s effect on lipid profiles and hope to provide further insights with the upcoming ARTEN study.”
The decision followed a positive recommendation by the Committee for Medical Products for Human Use (CHMP) and the scientific committee of the European Medicines Agency (EMEA).