The post-marketing surveillance (PMS) term for Sanofi’s hemophilia treatment ‘Eloctate’ and ‘Alprolix’ has been extended, and the number of subjects reduced.

With the risk that the items may be canceled if the company fails to complete PMS for the drugs within the term set within the year, the authorities decided to extend the reevaluation term, including the submission of the risk management plan (RMP), by 3 years to collect more cases in consideration of the need for various hemophilia treatments and how they are being used in the field.

The Ministry of Food and Drug Safety recently disclosed the results of the Central Pharmaceutical Affairs Council’s Drug Reexamination Subcommi