Cytokinetics (CYTK) Proposed Muscle Troponin Activator Now on FDA's Fast Track
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Cytokinetics, Inc. (Nasdaq: CYTK) reports that CK-2017357, its fast skeletal muscle troponin activator, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease. CK-2017357, the lead drug candidate from the company's skeletal sarcomere activator program, is currently in Phase II clinical trials intended to inform a potential registration program. Cytokinetics anticipates that results from two recently completed Phase II clinical trials, designed to assess the safety and tolerability of CK-2017357 in patients with ALS, will be presented at the American Academy of Neurology 64th Annual Meeting in New Orleans, LA on April 25, 2012.
Under the FDA Modernization Act of 1997, the Fast Track process was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. A potential drug that receives Fast Track designation is eligible for Accelerated Approval, which provides for a potential approval by the FDA on the basis of a demonstrated effect on a surrogate endpoint deemed reasonably likely to predict clinical benefit, and Rolling Review, which facilitates the submission of individual sections of a New Drug Application (NDA) as they are completed for review by FDA. In addition, Fast Track designation for a potential drug may allow more frequent meetings between the sponsor and FDA to discuss the proposed development plan and ensure collection of appropriate data needed to support approval, as well as possibly more frequent written correspondence from FDA about such matters as the suitability of designs for proposed clinical trials. Many drugs that are eligible for Fast Track designation are also considered appropriate to receive Priority Review, an additional designation that may reduce the time required for FDA review.
Under the FDA Modernization Act of 1997, the Fast Track process was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. A potential drug that receives Fast Track designation is eligible for Accelerated Approval, which provides for a potential approval by the FDA on the basis of a demonstrated effect on a surrogate endpoint deemed reasonably likely to predict clinical benefit, and Rolling Review, which facilitates the submission of individual sections of a New Drug Application (NDA) as they are completed for review by FDA. In addition, Fast Track designation for a potential drug may allow more frequent meetings between the sponsor and FDA to discuss the proposed development plan and ensure collection of appropriate data needed to support approval, as well as possibly more frequent written correspondence from FDA about such matters as the suitability of designs for proposed clinical trials. Many drugs that are eligible for Fast Track designation are also considered appropriate to receive Priority Review, an additional designation that may reduce the time required for FDA review.
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