The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can significantly cut down the development time and cost associated with bringing a drug to market, and the orphan-drug designation also allows for 7 years of market exclusivity even after expiration of related patents.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a rare neurodegenerative disease of unknown causes where the motor neurons necessary to move muscles in the body are destroyed, leading to paralyzation of all muscles, such as those in the tongue, neck, and the limbs. The disease occurs mostly in adults and average life expectancy is 2-5 years of symptoms onset. According to the National Institutes of Health (NIH), prevalence of ALS in the U.S. is 3.9 cases per 100,000 persons, and there are currently an estimated of 450,000 patients around the worldi. With roughly 20,000-30,000 patients in the U.S currently, there are an estimated 6,400 new patients are diagnosed with the diseased every year. (ref: ALS TDI, ALS Association).
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