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Sanofi's (SNY) Dupixent sBLA for Asthma Gets FDA Acceptance

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Sanofi (SNY - Free Report) announced that the FDA has accepted for review its supplemental biologics license application (sBLA) seeking approval for its blockbuster inflammatory drug Dupixent (dupilumab) as an add-on treatment of uncontrolled moderate-to-severe asthma in children aged six to 11 years.

A decision from the regulatory body is expected on Oct 21, 2021.

Notably, Dupixent is currently approved as an add-on treatment for treating uncontrolled moderate-to-severe asthma in patients aged 12 years and above with elevated eosinophils or oral corticosteroid dependent asthma.

Shares of Sanofi have declined 5.5% so far this year compared with the industry’s decrease of 2.1%.

price chart for SNY

We note that in October 2020, a pivotal phase III study evaluating Dupixent to treat uncontrolled moderate-to-severe asthma in children aged six to 11 years met its primary and all key secondary endpoints.

A regulatory filing for Dupixent to address moderate-to-severe asthma in children aged between six and 11 years is expected to be filed in the first quarter of 2021 in Europe.

We note that Dupixent is being jointly marketed by Sanofi and Regeneron (REGN - Free Report) under a global collaboration agreement. The medicine is already approved for treatment of severe asthma in adults as well as for two other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis and moderate-to-severe atopic dermatitis, in both the United States and Europe.

Dupixent is approved to treat moderate-to-severe atopic dermatitis in patients aged 6 years and above in the United States.

Dupixent generated sales of €3.5 billion in 2020, up 73.9% year over year. The frequent label expansion approvals are driving the drug’s sales higher, with the momentum expected to continue in the future quarters as well.

Meanwhile, Dupixent is also being studied for treating other diseases, such as bullous pemphigoid, chronic spontaneous urticaria, prurigo nodularis, eosinophilic esophagitis and chronic obstructive pulmonary disease, all in phase III evaluations. It is also being investigated in phase II studies for food allergies.

However, competitive pressure in the respiratory market intensified with the launch of AstraZeneca’s (AZN - Free Report) Fasenra and Glaxo’s (GSK - Free Report) Nucala.

Zacks Rank

Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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