EMA rejects Genzyme re-examination request for Kynamro

theflyonthewall.com

Genzyme, a Sanofi company, requested a re-examination of the Committee for Medicinal Products for Human Use previous adoption of a negative opinion recommending the refusal of the marketing authorization for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorization on March 21, the EMA announced earlier.

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