June 16 (Reuters) - Sanofi SA:
* REG-SANOFI’S INVESTIGATIONAL ENZYME REPLACEMENT THERAPY SHOWS CLINICALLY MEANINGFUL IMPROVEMENT IN CRITICAL MANIFESTATIONS OF LATE-ONSET POMPE DISEASE
* U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS GRANTED BREAKTHROUGH THERAPY AND FAST TRACK DESIGNATIONS TO AVALGLUCOSIDASE ALFA FOR TREATMENT OF PATIENTS WITH POMPE DISEASE.
* Avalglucosidase alfa showed a 2.4-point improvement in percent-predicted forced vital capacity, an important measure of respiratory function in Pompe disease, compared to alglucosidase alfa (standard of care)
* results underscore our ambition to establish avalglucosidase alfa as a new standard of care treatment for Pompe disease Source text for Eikon: Further company coverage: (Reporting by Sudip Kar-Gupta)