Merck Says FDA to Accelerate Development of Cladribine Rare Disease Treatment
By Aimee Look
Merck said the U.S. Food and Drug Administration is accelerating the development of its cladribine capsules, which are being studied as an oral treatment for a rare autoimmune neuromuscular disorder.
The life-sciences and chemicals group said Monday that the FDA granted Fast Track designation to the development process for the capsules, which are being studied in a phase 3 trial to become the first oral treatment for generalized myasthenia gravis.
Merck said it is also working with patient organizations and medical technology company Ad Scientiam for management of the rare disease.
The FDA's Fast Track program develops and accelerates therapies for conditions with unmet medical needs, Merck said. Cladribine falls under the Orphan Drug Designation for patients of rare diseases, which usually affect less than 200,000 U.S. patients.
Write to Aimee Look at aimee.look@wsj.com
(END) Dow Jones Newswires
November 24, 2025 08:39 ET (13:39 GMT)
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