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  • Reimb review for Pompe disease drug Nexviazyme underway
  • by Lee, Tak-Sun | translator Kim, Jung-Ju | Apr 10, 2023 05:53am
An upgraded version of existing Myozyme...first biobetter for rare disease to be approved
Reimbursement review is underway in Korea for Nexviazyme Inj (avalglucosidase alfa-ngpt), Sanofi¡¯s Pompe disease drug that had been approved by the Ministry of Food and Drug Safety on the 29th.

Nexviazyme is the first biobetter among rare disease drugs to be approved in Korea.

According to industry sources on the 7th, the Health Insurance Review and Assessment Service started the reimbursement review for Nexviazyme and requested the Ministry of Food and Drug Safety to confirm the drug¡¯s Target Product Profile.

Nexviazyme is regarded an upgraded version of the company's Myozyme.

The MFDS has been approving products with improved safety, efficacy, and use over existing approved biodrugs or those that wer
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