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news.The US Food and Drug Administration (FDA) has granted fast track designation for Marathon Pharmaceuticals' deflazacort to treat patients with duchenne muscular dystrophy (DMD), a fatal disorder that causes the progressive deterioration of muscle fibers.
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Deflazacort is a glucocorticoid with anti-inflammatory and immunosuppressant properties.
Currently, there are no approved therapies for DMD in the US, where it affects around 20,000 people.
The company is currently carrying out several clinical and preclinical trials of deflazacort to support approval in patients with DMD.
A new drug application (NDA) is expected to be submitted in early 2016 to the US FDA, which previously granted orphan drug designation to deflazacort to treat DMD.
Marathon chief executive officer Jeffrey Aronin said: "Marathon is committed to improving the lives of patients with Duchenne Muscular Dystrophy and other rare diseases.
"Fast Track designation for deflazacort is an important milestone for DMD patients and their families. We will work to take full advantage of this opportunity to accelerate availability to patients."
The company said that based on published clinical studies, deflazacort may be an important new treatment option for patients with DMD.