Axovant Sciences (AXON) Announces FDA Fast Track Status for Intepirdine
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Axovant Sciences Ltd. (NYSE: AXON) announced that the company has received Fast Track designation for its Investigational New Drug (IND) application for intepirdine in the treatment of dementia with Lewy bodies from the U.S. Food and Drug Administration (FDA).
"We are pleased that FDA has placed a high priority on the development of intepirdine as a potential treatment for dementia with Lewy bodies," stated Dr. Lawrence Friedhoff, Chief Development Officer of Axovant Sciences. "Dementia with Lewy bodies is the second-leading form of progressive dementia and affects over 1 million people in the United States and currently there are no approved treatments for the disease in either the United States or Europe. We believe the HEADWAY-DLB study of intepirdine in dementia with Lewy bodies represents an important step to address the unmet need of patients with this condition."
The ongoing HEADWAY-DLB study will evaluate over a 24-week treatment period the efficacy, safety and tolerability of intepirdine at doses of 70 mg and 35 mg daily in approximately 240 patients with dementia with Lewy bodies. The study permits patients currently receiving stable background therapy for dementia with Lewy bodies to participate.
The agency's Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
More information about FDA' Fast Track designation is available at the following address: www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
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