Novartis wet AMD drug receives EU approval

Novartis has announced that Lucentis (ranibizumab), its treatment for the improvement of vision in patients with wet age-related macular degeneration (AMD) has received approval from the European Union.

This approval follows regulatory submission for the compound based on studies showing an “unprecedented” response rate in patients, published in the New England Journal of Medicine.

In these studies, 95 per cent of patients treated with Lucentis maintained their vision, with 68 per cent gaining vision, with this gain sustained at two years of monthly treatment with the compound.

MacDonald Curran, chairman of AMD Alliance International, said: “The positive European Commission decision for Lucentis is a major breakthrough for the wet AMD community and gives hope to many of us.”

He added that the no-profit alliance looked forward to EU countries rapidly awarding the compound reimbursable status to avoid unnecessary blindness in patients.

The decision to approve the compound comes 11 months after submission to the regulatory authorities by the company, with Lucentis being launched throughout Europe over the next two years.

Lucentis received its first European approval as a treatment for wet AMD in patients over 50 in Switzerland in August 2006, with the product launched in that country in the following month.