logo
Plus   Neg
Share
Email

Europe Accepts Sanofi's Regulatory Submission For Enzyme Replacement Therapy For Pompe Disease

Sanofi (SNYNF,SNY) said that the European Medicines Agency or EMA has accepted to review the Marketing Authorization Application of avalglucosidase alfa, an investigational enzyme replacement therapy for the treatment of patients with Pompe disease.

The company expects to receive regulatory approval for the therapy in Europe in the second half of 2021.

Pompe disease is a rare, degenerative muscle disorder that can impact an individual's ability to move and breathe. It affects an estimated 50,000 people worldwide and can manifest at any age from infancy to late adulthood.

Avalglucosidase alfa has received Promising Innovative Medicine designation in UK, and also received U.S. Breakthrough Therapy designation earlier this year.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Santa Cruz Bicycles LLC has recalled certain model year 2020 bicycles with aluminum frames citing fall risks, according to the U.S. Consumer Product Safety Commission. The recall involves about 2,900 units of model year 2020 Auminum Santa Cruz and Juliana Bicycles. In addition, about 216 were sold in Canada. AstraZeneca is mulling an additional global trial to confirm the 90% efficacy rate of its Covid-19 vaccine candidate at lower dosage, Bloomberg news quoted Chief Executive Officer Pascal Soriot as saying. In an interview, Soriot noted that instead of adding the trial to an ongoing U.S. process, the company might launch a fresh study to evaluate efficacy of lower dosage of its vaccine that perform U.S. airline Delta Air Lines, Inc. and its Italian codeshare partner Alitalia are planning to launch quarantine-free, COVID-free flights between U.S. and Europe through new testing protocols, starting in December. In a statement, Delta said it has signed deals with airports and governments eliminating quarantine requirements on COVID-tested flights connecting Atlanta and Rome.
Follow RTT