Pfizer tafamidis listing application in China to be included in the priority review

On February 3, CDE official website showed that Pfizer chlorobenzoic acid soft capsule (tafamidis) was included in the planned priority review procedure according to four rare diseases in the priority review scope (II) Tafamidis is a kind of TTR stabilizer At present, the approved indications are family amyloid polyneuropathy and amyloid cardiomyopathy The drug was initially approved for marketing in the European Union on November 15, 2011, and was approved by FDA on May 7, 2019 On July 26, 2019, Pfizer's tafamidis listing application was accepted by the State Food and drug administration The amyloid polyneuropathy of the thyroxine transforming protein family is a rare disease, which results in amyloidosis with autosomal dominant inheritance due to gene mutation At present, there is no effective treatment Previously, the drug has been included in China's "first batch of clinically urgent overseas new drugs list".