The FDA Has Awarded Fast Track Designation to a Drug For PROS

The United States Food and Drug Administration has awarded Fast Track Designation to the investigational drug miransertib (ARQ 092), which is being researched as a potential treatment for PIK3CA-related overgrowth spectrum. For more detailed information you can view the source press release here, at Business Wire.

About PIK3CA-Related Overgrowth Spectrum (PROS)

PROS refers to a group of disorders that cause overgrowth of parts of the body. The group of rare conditions includes disorders such as MCAP syndrome, HHML syndrome, CLOVES syndrome, fibroadipose hyperplasia, and others. PROS is thought to be caused by changes to the PIK3CA gene. This information is sourced from the NIH, and you can click here to find out more.

About Miransertib (ARQ 092)

Miransertib is a drug that is being researched as a potential treatment for PROS. It may work by inhibiting AKT1, 2, and 3 isoforms. AKT dysregulation has been suggested to underlie several overgrowth diseases and cancers, but there are not currently any drugs approved to inhibit it. Miransertib is being investigated in a Phase 1/2 study for PROS.

Fast Track Designation

ArQule has announced that the US FDA has awarded miransertib Fast Track Designation for the treatment of PROS. Fast Track Designation is used by the FDA to speed up the review of drugs that could potentially treat serious conditions and fulfil an unmet medical need. Drugs that receive Fast Track Designation may be eligible for more frequent communication with the FDA, and rolling review (when the FDA reviews the sections of certain applications as they are submitted, rather than when the complete document is submitted), amongst other benefits. These are designed to help bring the new drugs to patients more quickly. To find out more about Fast Track Designation, click here.

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