According to a report from Dermatology Times, the FDA has granted Breakthrough Therapy designation to the topical whole-body treatment SD-101 for pediatric patients with epidermolysis bullosa. The novel agent was recently acquired from Amicus Therapeutics by Paradigm Therapeutics. In recent phase II and phase III trials, researchers enrolled 217 pediatric patients with simplex, recessive dystrophic, or junctional epidermolysis bullosa and demonstrated that SD-101 was safe and effective at treating wounds and lesions in all three subtypes of the condition. “We are excited about the opportunity to continue the development of SD-101 and … expedite a path forward toward registration of this therapy for patients with all [epidermolysis bullosa] subtypes,” concluded Robert Ryan, PhD, Chief Executive Officer of Paradigm Therapeutics, in a companion press release.
September 06, 2023