The FDA’s Fast Track process is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions to address an unmet medical need with the purpose of getting important new drugs to the patient earlier. Fast Track designation provides a company early and more frequent communication with the FDA to improve the efficiency of the investigational drug’s development and provides eligibility for priority review if certain criteria are met.
“This Fast Track Designation is an acknowledgement from the FDA of the importance of Emcitate to address the significant unmet medical need in MCT8 deficiency and ultimately help these patients that suffer from this rare and devastating disease. These patients are currently left without any treatment options. With a Fast Track designation come opportunities to expedite both the NDA submission and FDA’s review which can enable Emcitate’s regulatory approval sooner” said Nicklas Westerholm, CEO of Egetis Therapeutics.
A first clinical trial in patients suffering from MCT8 deficiency of all ages has been concluded with significant and clinically relevant results. A pivotal clinical trial looking at early intervention in very young MCT8 deficient children is under way. Recruitment is expected to be completed in Q4 2021. Emcitate has been granted Orphan Drug Designation in the US and EU. Emcitate was also granted US Rare Pediatric Disease Designation in November 2020, eligible to apply for a Priority Review Voucher.
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