French regulator requests information from Roche on off-label use of Avastin for wet-AMD

7 November 2014

The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé (ANSM), has contacted Swiss drug major Roche (ROG: SIX) to request information on off-label use of its cancer drug Avastin (bevacizumab) to treat wet age-related macular degeneration (wet-AMD).

Roche has three months to respond to the request, and the information provided will be combined with the ANSM’s own research and examined next year with a recommendation expected to be made public in the first half of 2015 with regards to risk-benefit.

The ANSM asked Roche for any available data on the safety profile and efficacy of Avastin in age-related macular degeneration. It also asked that the company account for how it will monitor patients treated with the drug for off-label uses. A spokesperson from Roche said: “we have received the letter regarding the evaluation process in wet AMD...and we will of course fully cooperate with the authorities."

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