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Sanofi's Dupixent Gets Breakthrough Status for New Indication

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Sanofi (SNY - Free Report) announced that the FDA granted Breakthrough Therapy designation to its inflammatory drug, Dupixent (dupilumab), for a new indication.

The FDA granted Breakthrough Therapy designation to Dupixent as potential treatment for eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly.

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

The designation for this indication was supported by positive data from part A of a pivotal, phase III study evaluating the drug in patients 12 years and older with EoE. Data showed that patients treated with 300 mg weekly disease of Dupixent achieved 69% and 60% reduction in disease symptoms and esophageal eosinophilic count, respectively, after 24 weeks of treatment. Esophageal eosinophilic count was reduced to normal range following the treatment. Moreover, treatment with Dupixent reduced abnormal endoscopic findings by 32%. All these improvements were clinically meaningful and part A of the study met its co-primary endpoints.

Currently, the company is enrolling patients in part B of the pivotal study which will evaluate an additional Dupixent dosing regimen. Part C of the study is also enrolling patients, which will evaluate patients who have completed either part A or B of the study for a 28-week extended active treatment period.

Shares of Sanofi have increased 3.3% so far this year against the industry’s decline of 0.2%.

Dupixent generated sales of €1.6 billion in the first half of 2020, up 98.1% year over year. Sales of the drug in the United States were €1.3 billion, up 95.8%, in the same period driven by continued growth in AD and a rapid uptake for new asthma indication besides its launch for chronic rhinosinusitis with nasal polyposis in June 2019.

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, the approval for a 300-mg, single-dose, pre-filled pen of Dupixent in June will likely boost sales due to ease of administration.

Zacks Rank & Other Stocks to Consider

Sanofi currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the large-cap pharma sector include GlaxoSmithKline plc (GSK - Free Report) and Global Blood Therapeutics, Inc. (GBT - Free Report) , both carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s earnings estimates have been revised 1.3% upward for 2020 and 1.6% for 2021 over the past 30 days.

Global Blood Therapeutics’ loss estimates have narrowed 3.4% for 2020 and 17.6% for 2021 over the past 30 days.

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