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Sanofi: Avalglucosidase Phase 3 Trial Shows Clinically Meaningful Improvement

Sanofi (SNY) said the company's investigational enzyme replacement therapy, avalglucosidase alfa, met the primary endpoint in a phase 3 trial demonstrating non-inferiority in improving respiratory function compared to alglucosidase alfa (standard of care) in patients with late-onset 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. Patients treated with avalglucosidase alfa walked 30 meters farther than those treated with standard of care. The safety profile of avalglucosidase alfa was found to be comparable to standard of care.

The company said the data from the phase 3 trial will form the basis for global regulatory submissions anticipated in the second half of the current year.

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