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Trikafta wins Canadian approval for Trikafta in children with cystic fibrosis

By Brian Buntz | April 20, 2022

Vertex PharmaceuticalsVertex Pharmaceuticals Inc. (Nasdaq: VRTX) has won marketing authorization for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis who are between the ages of 6 and 11 years old.

The latest approval covers children with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The approval allows an additional dosage strength of Trikafta tablets consisting of elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg, and ivacaftor 75 mg.

According to the company, the new approval will provide a treatment option to roughly 500 children.

“This important milestone brings us one step closer to our ultimate goal of developing treatments for all patients living with CF,” said Dr. Reshma Kewalramani, chief executive officer and president at Vertex. “We will now work closely with all provinces and territories to secure access for eligible patients as quickly as possible.”

Before winning the new approval, Vertex conducted a 24-week Phase 3 open-label, multicenter study enrolling 66 children between 6 and 11.


Filed Under: Uncategorized

 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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