US and European regulators will review a Vertex Pharmaceuticals Inc. application to sell a new two-drug combination that treats cystic fibrosis, the company said Thursday.
If approved, the medicine would be the third product marketed by Boston-based Vertex that’s aimed at improving lung function in patients with cystic fibrosis, an obstructive lung disease that afflicts about 75,000 people worldwide.
In the United States, the Food and Drug Administration said it expects to make a decision on the Vertex application by the end of next February. Officials at the European Medicines Agency, the regulatory body that reviews drug applications there, didn’t commit to a specific decision date.
Vertex already has two drugs on the market — Kalydeco and Orkambi — that treat patients with different cystic fibrosis-causing genetic defects. Nearly 14,000 patients in the United States are eligible to take one of those drugs. Some of them could potentially switch to the new combination therapy, which may also treat other CF patients who currently aren’t taking Kalydeco or Orkambi.Robert Weisman can be reached at firstname.lastname@example.org. Follow him on Twitter @GlobeRobW.