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Sanofi (SNY) Pompe Disease Drug Receives FDA's Approval

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Sanofi SNY announced that the FDA has granted approval to its enzyme replacement therapy, avalglucosidase alfa, for the treatment of late-onset Pompe disease, a rare degenerative muscle disorder. The drug will be marketed by the trade name of Nexviazyme.

The approval was based on data from two pivotal studies, which include both infantile-onset and late-onset Pompe disease (“LOPD”) patients.

So far this year, Sanofi’s shares have risen 4.7% against the industry’s 14.1% decline.

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Pompe disease causes a debilitating deterioration of the muscles resulting in decreased respiratory function and mobility in affected patients. It affects an estimated 3,500 people in the United States.

Nexviazyme targets the M6P receptor, the key pathway for cellular uptake of enzyme replacement therapy. In a phase III study called COMET, Nexviazyme resulted in improvements in respiratory function and walking distance in patients with LOPD. In the study treatment with Nexviazyme led to a 2.9-point improvement in forced vital capacity (FVC) percent-predicted at Week 49, the study’s primary endpoint. Treatment with Nexviazyme led to a 2.4-point greater improvement in FVC percent-predicted compared to treatment with alglucosidase alfa at Week 49 meeting the measurement of non-inferiority.

A similar application for avalglucosidase alfa is under review in the EU. Last month, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approving avalglucosidase alfa. However, the CHMP considered that avalglucosidase alfa does not qualify as a New Active Substance (“NAS”), which means a substance not previously authorized as a medicinal product in the EU. Sanofi plans to request a re-examination of the CHMP opinion for the NAS decision.

Amicus Therapeutics FOLD is also developing AT-GAA, a differentiated biologic for LOPD. In the United States, the company has completed rolling biologics license application for AT-GAA. In the EU, Amicus anticipates its approval in second-half 2021.

Sanofi currently has a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the drug/biotech sector include AstraZeneca AZN and Ironwood Pharmaceuticals, Inc. IRWD, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AstraZeneca’s earnings per share estimates have risen from $2.61 to $2.67 for 2021 and from $3.25 to $3.54 for 2022 in the past 30 days. The stock has risen 12.9% so far this year.

Ironwood’s earnings per share estimates have moved north from $1.05 to $1.08 for 2021 and from $1.18 to $1.22 for 2022 in the past 30 days. The stock has risen 17.2% so far this year.


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Sanofi (SNY) : Free Stock Analysis Report

AstraZeneca PLC (AZN) : Free Stock Analysis Report

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Amicus Therapeutics, Inc. (FOLD) : Free Stock Analysis Report

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