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Sanofi's Dupixent Meets All Goals in Asthma Study for Children

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Sanofi (SNY - Free Report) announced that a pivotal phase III study evaluating its blockbuster inflammatory drug Dupixent (dupilumab) to treat uncontrolled moderate-to-severe asthma in children aged from six to 11 years met its primary and all key secondary endpoints.

Data from the study showed that treatment with Dupixent plus the standard of care significantly reduced severe asthma attacks by 65% over a year in the given patient population compared to the standard of care alone. Moreover, Dupixent significantly and rapidly improved the lung function in children within two weeks of treatment, which sustained for up to 52 weeks, underlining the well-established safety profile of Dupixent.

Regulatory filings for Dupixent to address moderate-to-severe asthma in children aged between six and 11 years are expected to be filed in the first quarter of 2021, both in the United States and 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 to treat 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 dermatitisin 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.

Shares of Sanofi have increased 1.7% so far this year compared with the industry’s rise of 0.5%.

Dupixent generated sales of €1.6 billion in the first half of 2020, up more than 90% 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 evaluation. It is also being investigated in phase II studies for peanut allergy and grass pollen allergy.

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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