The US Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug (PRX004) for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), according to a recent press release.
This regulatory designation is aimed at accelerating the development and review of therapies for serious conditions with significant unmet medical needs.
“We are pleased that the FDA has granted Fast Track Designation for coramitug, a recognition that reflects both the seriousness of ATTR-CM and the significant unmet need that remains for people living with this life-threatening disease, despite standard of care,” said Michelle Lim-Watson, associate portfolio vice president, Cardiovascular Disease and Rare Diseases, US R&D, Novo Nordisk.