Takeda's Velaglucerase Alfa Approved in China for Gaucher Disease Treatment

Source: Pharma Insight

On April 29, the National Medical Products Administration (NMPA) of China announced that velaglucerase alfa for injection, marketed by Shire, a subsidiary of Takeda, has been approved for marketing. According to public information, the approved indication for this drug is Gaucher disease.

Publicly available information indicates that velaglucerase alfa for injection is a hydrolytic, lysosome-specific glucocerebrosidase. This drug is designed to replace the deficient glucocerebrosidase in patients with type 1 Gaucher disease and possesses the same amino acid sequence as the naturally occurring enzyme in the human body. In February 2010, velaglucerase alfa for injection was approved for marketing in the United States for long-term enzyme replacement therapy in children and adults with type 1 Gaucher disease, under the brand name Vpriv.

In China, velaglucerase alfa for injection was included in the first batch of the List of Overseas New Drugs Urgently Needed for Clinical Use by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in 2018. In February 2019, the CDE accepted the marketing application for velaglucerase alfa for injection. This approval means that this urgently needed overseas new drug will benefit patients with Gaucher disease in China.

Note: This article aims to introduce advances in pharmaceutical and health research and does not constitute recommendations for treatment regimens. For guidance on treatment plans, please consult a reputable hospital.

References:

[1] National Medical Products Administration of China Government Service Portal. Retrieved Apr 29, 2021, https://www.nmpa.gov.cn/zwfw/zwfwzhcx/index.html

[2] Vpriv (Velaglucerase alfa) Official Website. From https://www.vpriv.com/treating-type-1-gaucher

▽Follow [WuXi AppTecDe】WeChat Official Account