Lipocine Inc. (LPCN), a biopharmaceutical firm, announced on Tuesday that the U.S. Food and Drug Administration (FDA) has awarded Fast Track Designation to LPCN 1148, its investigational drug aimed at treating sarcopenia. Sarcopenia is characterized by the progressive decline of muscle mass and function, specifically in individuals suffering from decompensated cirrhosis.
The National Institutes of Health defines decompensated cirrhosis as a sudden and significant deterioration in liver function in patients who already have cirrhosis.
This Fast Track Designation entails numerous benefits, such as increased opportunities for communication with the FDA, eligibility for accelerated approval and priority review should specific conditions be fulfilled, and the advantage of a rolling review process. This process allows the company to submit and have sections of its application assessed incrementally, rather than waiting for the entire application to be finalized.
Currently, a Phase 2 study of LPCN 1148 is in progress.
