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FDA approves first two drugs for fatal lung disease

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FDA approves first two drugs for fatal lung disease

The US Food and Drug Administration (FDA) on Wednesday approved the first two drugs that can be used for treatment of a fatal lung disease.

The FDA's approval could prove beneficial for several patients but would also a spark a debate over high drug prices.

The drugs, Roche's Esbriet and Boehringer Ingelheim?s Ofev, are meant to treat idiopathic pulmonary fibrosis, a scarring of the lungs. The drugs would not treat the disease but will slow the rate at which lung function declines in patients suffering from this disease.

"It's very exciting to have two approved therapies now for a disease for which there were no approved therapies," said Daniel M. Rose, chief executive of the Pulmonary Fibrosis Foundation, an advocacy group that gets some funding from drug companies. "There's a lot of enthusiasm and excitement within the patient community."

Rose, however, expressed concern over the willingness of the insurers to pay for the drugs.

Roche said the wholesale price of Esbriet would be about USD 7,800 a month, or about USD 94,000 a year. The price is two to three times more than what it in Canada and Europe.

Boehringer executives however declined to disclose the price of Ofev saying they will reveal the price only when the drug became available, which is set to happen in 10 days.

Drugs are often costly in the US than in other industrialized countries because other countries keep cost down by applying government pressure or price controls.

The price disparity for new drugs, however, is usually much smaller than it is for Esbriet.

"This is yet another example of how we're all being asked to disproportionately fund world pharmaceutical profits," Dr. Steven Miller, chief medical officer of Express Scripts, the largest pharmacy benefits manager, said.


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