Lipocine Inc. (LPCN), a biopharmaceutical company, Tuesday said that the U.S. Food and Drug Administration or FDA has granted Fast Track Designation to LPCN 1148, the company's drug candidate for the treatment for sarcopenia, a progressive loss of muscle mass and function, in patients with decompensated cirrhosis.
According to National Institutes of Health, decompensated cirrhosis is an acute deterioration in liver function in a patient with cirrhosis.
Fast Track Designation provides several benefits including more frequent communication with the FDA, eligibility of accelerated approval and priority review if certain criteria are met, eligibility of rolling review, that is, the company can submit completed sections of its application for review rather than waiting until the entire application is complete.
A Phase 2 study of LPCN 1148 is underway.
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