Astellas Pharma (TSE:4503) has revealed that the FDA has slapped a clinical hold on its Phase 1/2 FORTIS Pompe disease study after observing a serious adverse event (SAE) — peripheral sensory neuropathy — in a trial participant. Peripheral sensory neuropathy results from damage to nerves outside of the central nervous system. The condition can lead…
FDA approves Sanofi’s Nexviazyme for late-onset Pompe disease
With its recent approval of Nexviazyme (avalglucosidase alfa-ngpt), Sanofi (NSDQ:SNY) has asserted its control over the Pompe disease landscape. In 2006, FDA approved Genzyme’s Myozyme (alglucosidase alfa) for Pompe disease. Sanofi acquired the company a decade ago. Additionally, FDA approved Lumizyme in 2010, which uses the same biologic, but is indicated for patients eight years of…