Sanofi Says EU Conditional Approval Recommended for Rezurock in Graft-versus-Host Disease

MT Newswires Live01-30

Sanofi's (SNY) Rezurock has been recommended for a conditional marketing authorization in the EU to treat chronic graft-versus-host disease in adults and children at least 12 years old, the company and the European Commission said separately Friday.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended that Rezurock be used when other treatment options either give limited clinical benefit, are not suitable, or have been exhausted, the Commission said, adding that the recommendation was made after a re-examination of the prior negative opinion issued by the committee.

Separately, Sanofi said the Commission is expected to issue a final decision in the "coming weeks."

The company also said it will conduct a confirmatory randomized controlled study.

Rezurock is currently approved in 20 countries, including the US, UK, and Canada, for the treatment of chronic graft-versus-host disease, a condition in which donor cells of a bone marrow or stem cell transplant attack the host body.

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