Tyr Pharma's Resolaris has been granted Fast Track designation by the Food and Drug Administration.
The medication was developed to treat facioscapulohumeral muscular dystrophy (FSHD). It is the only therapeutic candidate to receive Fast Track designation from the FDA for the treatment of FSHD. The drug is being assessed in a Phase1b/2 clinical study.
"This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical needs, represents another step forward for our rare muscle disease franchise," Tyr Pharma CEO John Mendlein said. "This designation highlights the significant need to develop and ultimately approve meaningful new therapeutics to treat patients with rare myopathies, such as FSHD."
The FDA created the Fast Track designation process to further advance development and hasten the review of prospective drugs, biologics and treatments. When the Biologic License Agreement (BLA) is filed, some product candidates may be authorized for priority review and could potentially have their completed BLA sections submitted on a rolling basis.
Resolaris is the focus of an ongoing Phase 1b/2 clinical trial for the potential treatment of three types of rare myopathies.