China’s Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its SRD4610, an in-house developed compound Chinese medicine, for the treatment of amyotrophic lateral sclerosis (ALS). This designation highlights the potential impact of SRD4610 in addressing the unmet medical needs of ALS patients.
Significance of Orphan Drug Designation
The Orphan Drug Designation by the FDA is a significant recognition that aims to encourage the development of drugs intended to treat rare diseases. Amyotrophic lateral sclerosis, a progressive neurodegenerative disease, affects nerve cells in the brain and spinal cord, leading to muscle weakness and eventually respiratory failure. The designation of SRD4610 as an orphan drug underscores the urgency and importance of finding effective treatments for ALS.
Phase II Study Completion in China
SRD4610 has successfully concluded a Phase II study in China for the indication of ALS. The completion of this study marks a crucial step in the drug’s development process, bringing it closer to potential regulatory approval and commercialization in the treatment of ALS.-Fineline Info & Tech
