June 16, 2020 / 12:04 PM / a month ago

BRIEF-Sanofi’S Investigational Enzyme Replacement Therapy Shows Clinically Meaningful Improvement In Critical Manifestations Of Late-Onset Pompe Disease

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)

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