FDA accepts new drug application for Pfizer's drug tafamidis

today, Pfizer announced thatFDA(http://has accepted its application fornew
drug(http://(NDA) for the treatment of trans-thyroxine amyloid cardiomyopathy (ATTR-CM
)http://this NDA includes two dosage forms, the tamamine (meglumine form) dosage form and the free acid (free acid form) dosage form, of which the plybuttamine dosage form (20 mg capsule) has been qualified for fda-issued priority review and is expected to be approved by July 2019Free acid forms (61 mg capsules) are expected to be approved by November 2019About Tafamidis
Tafamidis is a small molecule oral drug that selectively binds to specific sites of TTR tetrapolymers to prevent the formation of ATTR-CM amyloid protein due to its destabilisationin 2012, tafamidis was granted orphan drug status in both the European Union and the United StatesIn May 2017 and March 2018, the FDA issued fast-track qualifications and breakthrough therapies for tafamidisIn March 18, Japan's Ministry of Health, Labour and Welfare also issued sAKIGAKE qualification (pioneer qualification) to tafamidis related studies
the NDA submission is based on the results of the key 3 trial (http:// ATTR-ACT The 30-month trial reached its main endpoint, i.e tafamidis significantly reduced all-cause mortality and cardiovascular-related hospitalization rates in patients with wild type or mutation (hereditary) ATTR-CM compared to placebo, with a 30 percent lower risk of death and a 32 percent reduction in cardiovascular-related hospitalization rates in addition , tafamidis demonstrates good tolerance and safety The findings were presented at the Conference (http:// in Munich, Germany, and published online in the New England Journal of Medicine (NEJM)