The U.S. Food and Drug Administration said Thursday it had approved the use of Vertex Pharmaceuticals’ Orkambi, a drug aimed to treat patients with cystic fibrosis, on patients who are at least 12 years old.
The company’s shares were temporarily halted, up 3.73 percent at $130.90, during late-morning trading for pending news ahead of the announcement at 11:47 a.m. ET. Trading started again around 3 p.m. ET, and Vertex closed the day slightly higher than its halt price.
“…The approval of ORKAMBI represents a fundamental change in the treatment of the most common form of CF, marking significant progress for us and for the entire CF community,” Dr. Jeffrey Leiden, Vertex’s chairman, president and CEO, said in a statement.
With the approval, Orkambi will be available to about 8,500 patients in the United States, according to Reuters.
Cystic fibrosis is caused by a defective gene that disrupts the function of the lungs and digestive system, producing a build-up of thick, sticky mucus leading to inflammation and recurrent bacterial infections..