FDA approves expanded use of Vertex Pharma's cystic fibrosis drug
Thursday, September 29, 2016
Vertex Pharamceuticals Inc said the U.S. Food and Drug Administration expanded the use of its cystic fibrosis drug to treat a new subgroup of patients with the rare genetic disorder.
The company, however, cut its 2016 sales forecast for the drug, Orkambi, sending its shares down as much as 4 percent in after-market trading on Wednesday.
Vertex cited a slower-than-anticipated launch in Germany and slower refills during July and August for the cut.
The company said it now expects Orkambi revenue of $950 million to $990 million, down from $1.0 billion to $1.1 billion it had previously forecast.
The FDA approved the use of Orkambi in children with cystic fibrosis aged 6-11 who have a type of the mutation. The drug is already approved for use in patients aged 12 and older with a similar mutation.
"(The) approval in people ages 6 through 11 will drive growth in the U.S. in the fourth quarter," the company said.
Cystic fibrosis is a life-threatening condition, where a defective gene disrupts the function of the lungs and digestive system, producing a build-up of thick, sticky mucus leading to inflammation and recurrent bacterial infections.
The company's shares recouped some of their losses to be down less than a percent in extended trading. Up to Wednesday's close of $88.84, the stock had fallen about 29 percent this year.
Source : reuters.com
