Avastin

15.6.2015

Question for written answer E-009771-15
to the Commission
Rule 130
Ashley Fox (ECR)

The drug Avastin has recently been found to be safe and effective in clinical trials for the treatment of patients with age-related macular degeneration (AMD). Switching to this drug from the currently approved treatment, Lucentis, could save the UK’s NHS GBP 100 million every year. Avastin and Lucentis have both been approved by the EU regulatory authorities, but for different uses (Lucentis for use in the eye and Avastin for use in cancer patients). In order for Avastin to be licensed for treatment of AMD the manufacturer must apply for a new licence, but a request has not been submitted by the owners.

Is there a legal process by a which a drug can be licensed for a treatment other than that prescribed by the existing licence?