Vertex Pharmaceuticals announced positive results from its once-daily new CFTR Modulator vanzacaftor/tezacaftor/deutivacaftor (the “vanza triple”) program. The new “vanza triple” combo was similar to Trikafta at maintaining short-term lung function and superior to Trikafta in lowering levels of sweat chloride for eligible CF patients.

Vertex is on track to make global regulatory submissions by mid-2024 including a New Drug Application (NDA) to the Food and Drug Administration and a Marketing Authorization Application with the European Medicines Agency for people with CF ages 6 years and older. The company will use a priority review voucher in the U.S. The priority review voucher entitles the holder to designate an NDA for priority review, which provides an expedited 6‑month review instead of the standard 10-month review.

“We are very pleased with today’s results, which demonstrate the vanza triple is non-inferior to Trikafta in improving lung function and superior to Trikafta in lowering levels of sweat chloride in people living with CF, setting a new standard for the level of CFTR protein function achievable, and raising the very high bar set by Trikafta,” said Carmen Bozic, MD, executive vice president, global medicines development and medical affairs, and chief medical officer at Vertex, in the company’s press release.

“The efficacy seen with the vanza triple gives me great hope for CF patients in the future,” added Bonnie Ramsey, MD, co-chair of Vertex’s CFTR modulator steering committee and professor emerita at the University of Washington School of Medicine.

The company’s press release here.