Mirum’s CTEXLI™ (chenodiol) Tablets Receives FDA Approval for Treatment of Cerebrotendinous Xanthomatosis (CTX)
Mirum Pharmaceuticals, Inc. - common stock (MIRM)
Last mirum pharmaceuticals, inc. - common stock earnings: 3/12 04:02 pm
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Source: Business Wire
CTEXLI is the first and only medication approved for the treatment of CTX in adultsApproval based on Phase 3 RESTORE study resultsCTEXLI granted U.S. FDA Orphan Drug exclusivity for the treatment of CTX FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). CTEXLI is the first and only treatment approved for this rare, progressive and debilitating disease.The approval is based on data from the Phase 3 RESTORE study evaluating the safety and efficacy of CTEXLI in adult patients with CTX by measurement of urine bile alcohols and other secondary measures. The primary endpoint of reduction in bile alcohols (urine 23S-pentol) was highly statistically significant (pIn CTX, a deficiency of the bile acid chenodeoxycholic acid (CDCA) leads to a buildup of bile alcohols which pr
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