Generic Drug Gets 6,000 Percent Price Increase From Illinois Company

NORTHBROOK, IL — The U.S. Food and Drug Administration gave approval Thursday to Marathon Pharmaceuticals to sell a drug by the brand name of Emflaza, previously sold under the generic name deflazacort, to treat Duchenne muscular dystrophy, a rare genetic disorder that causes progressive muscle deterioration and weakness.

The company intends to charge $89,000 a year for a drug which has been available in Canada, the U.K. and Europe for decades for $1,000-$1,600 a year, according to the Wall Street Journal.

Essentially, Marathon is being rewarded for going through the process of getting a brand new drug approved, even though it has been on the market for years.

Now, Northbrook-based Marathon Pharmaceuticals LLC gets a seven-year monopoly on the drug, as part of the Orphan Drug Act (which provides incentives for developing drugs for rare diseases, except in this case, Marathon didn't develop it at all, it "mostly relied on clinical trial data from the 1990s that had not been fully analyzed," writes Rachel Sachs on a Harvard Law blog.)

The new monopoly price represents a 5,000-7,000 percent increase in price for what patients currently pay for imported versions of the generic deflazacort.

A user on the Parent Project for Muscular Dystrophy wrote Saturday, "I don't understand why I am no longer able to receive my sons prescription through the same pharmacy we have been using for years. Why is the company making Emflaza creating this monopoly? Why has this choice been taken away from me?"

Announcing the approval, the FDA said it granted the application fast track designation and priority review.

That priority review shortened the regulatory process by months, and Thursday's FDA announcement cleared the way for the drug to be prescribed to all boys age 5 and older and for Marathon to begin selling the Emflaza (deflazacort) for seven years at whatever price it determines appropriate.

"Marathon is committed to providing the most comprehensive, robust patient support programs allowed by law to qualifying patients," said the company's announcement of the FDA's decision. Marathon Pharmaceuticals did not respond to a request for comment Monday.

UPDATE: Marathon CEO Jeff Aronin announced the company's "commercialization efforts" are being put on hold.