FDA Approves Muscular Dystrophy Drug, Will Cost Patients $89000

FDA Approves Muscular Dystrophy Drug, Will Cost Patients $89000

FDA Approves Muscular Dystrophy Drug, Will Cost Patients $89000

A drug company may be facing some heat after doing something similar to Martin Shkreli, the hated man accused of jacking up the price of a life-saving drug just to make some more money.

While corticosteroids are the standard treatment commonly used globally to treat DMD, this is "the first FDA approval of any corticosteroid to treat DMD and the first approval of deflazacort for any use" in the US, the agency said.

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.

Emplaza is a corticosteroid that reduces activity within the immune system and decreases inflammation.

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Because it's been available outside the U.S.at such lower prices, many have said the Northbrook, Illinois-based Marathon's price is unjustifiably high. FDA approval should also increase access to a drug that may be too expensive to buy outright for some, even in its generic form.

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

Deflazacort is used to treat Duchenne muscular dystrophy (DMD), a rare genetic disease that causes heart and respiratory conditions, usually in younger men.

Sanders and Cummings noted that the drug has been imported by patients in the US for "decades". The drug now costs $1,200 overseas.

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A drug to treat muscular dystrophy will hit the USA market with a price tag of $89,000 a year despite being available for decades in Europe at a fraction of that cost. Sarepta's drug treats a subset of DMD patients representing about 13% of the total.

One hundred and ninety-six male patients, who ranged in age from 5 to 15 years old, had a mutation of the dystrophin gene, and had the onset of weakness before they were five years of age, participated in a clinical study of the drug deflazacort.

Sanders and Cummings accused the company of taking advantage of the FDA's orphan drug program, which will give it seven years of exclusive sales rights on the treatment. It was also awarded a rare pediatric disease priority review voucher that can be used for another drug. The drug isn't a cure, but it has been shown to improve muscle strength, the FDA said in a statement announcing the approval. Fundamentally, the voucher is a way to get a future drug reviewed faster by regulators. An overall stability in average muscle strength was maintained through the end of study at week 52 in the deflazacort-treated patients. Other side effects include mood swings, elevated blood pressure, infection and serious skinj rashes.

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