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FDA approves expanded use of Vertex Pharma's cystic fibrosis drug
September 28, 2016 / 10:20 PM / a year ago

FDA approves expanded use of Vertex Pharma's cystic fibrosis drug

Sept 28 (Reuters) - 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.

Reporting by Dipika Jain in Bengaluru; Editing by Sriraj Kalluvila

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