News about the new triple combination of vanza triple drugs

Cystic fibrosis (CF) is a rare genetic disease that affects not only the lungs, but also the pancreas, liver, kidneys and intestines. Cystic fibrosis, Disease detection and treatment, Puzzle lettering

The acceptance of the US Food and Drug Administration’s (FDA) application for the new vanza triple drug combination vanza triple for the treatment of Cystic Fibrosis was announced earlier this month by Vertex.

According to the company’s press release, the US Food and Drug Administration (FDA) has agreed to review the application for the new drug vanza triple as a priority and is expected to issue its decision in 6 months, by 2/1/2025. The new vanza triple combination drug vanza triple is targeted at patients with Cystic Fibrosis over 6 years of age, with at least one F508del mutation or another mutation that may respond to this treatment.

At the same time, the company announced that the application submitted to the European Medicines Agency (EMA) for marketing authorisation of this new combination of medicines in the European Union has been validated. Applications for the new medicine have been submitted in Canada, Australia, Switzerland and the United Kingdom.

The triple therapeutic combination of vanza triple drugs is taken once a day and includes Vanzacaftor/Tezacaftor/Deutivacaftor. Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein on the cell surface by facilitating the processing and trafficking of CFTR protein. Deutivacaftor is an enhancer designed to increase the possibility of an open channel of CFTR protein on the cell surface to improve the flow of salt and water across the cell membrane.

“The FDA acceptance of the vanza triple combination drug vanza triple and the validation of the application by the EMA represent significant milestones in the decades-long development of CFTR Modulator therapies and another example of our history of innovation in Cystic Fibrosis,” said Nia Tatsis, Ph.D. , Executive Vice President, Chief Regulatory and Quality Officer of Vertex. “Vanzacaftor raises the high bar set by Trikafta/Kaftrio and gives more patients with Cystic Fibrosis the opportunity to reach sweat chloride levels below the diagnostic threshold for the disease, and even sweat chloride levels seen in people without Cystic Fibrosis.”

More information in the company’s Press Release: https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-fda-acceptance-new-drug-application