Benzinga | Jun 18, 2021 03:38PM EDT

Vertex Reports Health Canada Granted Marketing Authorization For TRIKAFTA In People 12+ With At Least 1 F508del Mutation

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced Health Canada has granted Marketing Authorization for TRIKAFTA(r) (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation. With this approval, for the first time, approximately 1,100 eligible patients with CF ages 12 years and older who have at least one F508del mutation have a medicine that targets the underlying cause of their CF.

"The approval of TRIKAFTA marks a significant milestone for Canadians with CF, their families and Vertex," said Reshma Kewalramani, M.D., Chief Executive Officer and President, Vertex. "I would like to thank the people with CF who participated in our clinical trials, our dedicated scientists and the investigators who have enabled this innovative medicine to be approved in Canada today. Without their commitment, this milestone would not have been possible."

"I have seen substantial improvements in patients treated with TRIKAFTA in clinical practice, including improved lung function," said Dr. Elizabeth Tullis, Medical Director, Toronto Adult CF Centre, Professor of Medicine, University of Toronto. "I'm excited that more Canadians may be able to benefit from CFTR modulators and look forward to seeing the impact of this medicine for all patients who can benefit from it."