, to support a patient-directed approach to the future management of gMG.

If approved, cladribine capsules, currently being studied in the global Phase 3 MyClad trial, could become the first oral treatment for gMG, a rare autoimmune neuromuscular disorder that causes severe muscle weakness and significantly impacts patients’ lives. The FDA’s Fast Track program is designed to facilitate the development and accelerate the review of therapies for serious conditions with unmet medical needs, potentially bringing treatments to patients sooner. The FDA Orphan Drug Designation is designed to encourage the development of treatments for rare diseases or conditions, often defined as those affecting fewer than 200,000 patients in the U.S.

“The FDA’s Fast Track designation, together with Orphan Drug Designation, affirms that more treatments are needed for the gMG community,” said David Weinreich, MD, Global Head of R&D and Chief Medical Officer, Healthcare
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