Boehringer Ingelheim receives EC backing for Viramune label change

Boehringer Ingelheim has been granted permission to amend the European labelling of its HIV drug Viramune, making the treatment accessible to more patients.

The European Commission (EC) has approved an update to Viramune's summary of product characteristics which allows patients with an undetectable viral load to switch to treatment with the drug, regardless of their CD4 count.

This amendment follows a recommendation from the European Medicines Agency's Committee for Medical Products for Human Use, based on clinical evidence showing that switching to Viramune will not cause these patients to suffer an increased risk of hypersensitivity or hepatotoxicity.

Professor Jurgen Rockstroh of the University of Bonn said the new ruling represents "good news" for HIV sufferers and their doctors.

He added: "Prescribing physicians will now no longer have to apply the CD4 count threshold when switching patients to a lipid-friendly regimen containing Viramune."

Earlier this month, Boehringer Ingelheim published data from a new clinical study demonstrating the effectiveness of its telmisartan/amlodipine combination therapy for high blood pressure.