Generic Drug Gets 6000% Price Increase From Marathon

Feb 14, 2017, 00:14

In an interview, Marathon CFO Babar Ghias noted the company will likely receive much less in net revenue than the list price, after providing discounts to government insurers and financial support to patients who can not afford the medication. This is the first corticosteroid approved by the FDA to treat patients who have Duchenne muscular dystrophy.

The two congressmen, who have previously eyed Valeant, Turing, and Mylan, among other pharma firms, on Monday wrote a letter to Marathon Pharmaceuticals seeking answers about its newly approved $89,000 treatment for Duchenne muscular dystrophy. Emflaza is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system.

"This is the first treatment approved for a wide range of patients with Duchenne muscular dystrophy, " said Billy Dunn, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

Marathon's chief financial officer defended the new price tag for deflazacort by claiming it is "modestly priced for an orphan drug".

Deflazacort has always been used off-label for DMD treatment, but until now hadn't been approved to treat the condition.

Sanders and Cummings noted that the drug has been imported by patients in the US for "decades".

A USA Today report reveals the drug, a steroid known as deflazacort, will cost patients a whopping $89,000 per year, almost 70 times higher than buying the drug in other countries. Marathon, the company that owns Emflaza, did not invent deflazacort, and patients have been able to import it cheaply for for years since it hadn't been approved in the US.

The U.S. Food and Drug Administration is now approved Emflaza (deflazacort), an old steroid treatment, long accessible outside the United States. Sarepta's drug treats a subset of DMD patients representing about 13% of the total. It improves muscle strength.

Announcing the approval, the FDA said it granted the application fast track designation and priority review. An overall stability in average muscle strength was maintained through the end of study at week 52 in the deflazacort-treated patients. Patients lack a protein called dystrophin that's essential for healthy muscle, and eventually lose the ability to walk, stand and breathe. This is the 9th time that the FDA grants the pediatric disease priority voucher.

Emflaza side effects are similar to other corticosteroids, such as puffiness of the face, weight gain, increased appetite, infection of the upper respiratory tract, fequent urination, stomach fat, cough, and unwanted hair growth.

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