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Regeneron (REGN), Sanofi's Dupixent Gets EU Nod for Asthma in Kids
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Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the European Commission (EC) has approved the expanded use of their blockbuster drug Dupixent (dupilumab) in children aged 6-11 years with severe asthma.
With the label expansion approval, Dupixent becomes the only biologic approved in the European Union as an add-on maintenance therapy to treat severe asthma with type 2 inflammation in individuals aged six years and older. The severe asthma in such patients should be characterized by raised blood eosinophils (EOS) and/or raised fractional exhaled nitric oxide (FeNO).
The EC decision is based on data from the phase III LIBERTY ASTHMA VOYAGE study, which evaluated the efficacy and safety of Dupixent plus the standard-of-care asthma therapy (SOC) in children with uncontrolled moderate-to-severe asthma. The study pre-specified participants into two groups. The first group comprised patients with baseline blood EOS of at least 300 cells/μl and the second group consisted of patients either with baseline FeNO of at least 20 parts per billion or baseline blood EOS of at least 150 cells/μl.
Data from the study demonstrated that compared to placebo, the Dupixent-SOC combo substantially reduced asthma attacks by an average of 65% and 59% in the first and second groups, respectively. Participants in both groups administered with the Dupixent-SOC combo also showed improvements in lung function, asthma control and health-related quality of life compared to placebo.
Shares of Regeneron have risen 12.2% so far this year against the industry’s 12.1% decline.
Image Source: Zacks Investment Research
Sanofi’s stock has increased 8.1% in the year so far compared with the industry’s 7.4% rise.
Image Source: Zacks Investment Research
Dupixent is also approved by the FDA for a similar indication (asthma) for individuals aged six years and above. The drug received an approval for expanded use in the 6-11 years’ age bracket last October. The FDA nod was also based on data from the LIBERTY ASTHMA VOYAGE study.
Dupixent is jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with the global sales of the drug.For 2021, Dupixent generated global sales worth $6.2 billion, reflecting a 53% year-over-year rise.
Apart from asthma, Dupixent is approved to treat moderate-to-severe atopic dermatitis in patients aged six years and older, and for use with other medicines for maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled in the United States, Europe and some other countries.
Currently, Dupixent is the leading driver of growth for both Regeneron and Sanofi. Continued label expansion of the drug boosted both sales and profits, making it an important contributor to both companies.
Earlier this week, both Regeneron and Sanofi announced that the FDA accepted a supplemental biologics license application (sBLA), seeking label expansion of Dupixent (dupilumab) for eosinophilic esophagitis indication. The FDA’s decision is expected by Aug 3, 2022. Similarly, another verdict by the regulatory agency is expected by Jun 9, 2022, for another sBLA, which seeks an approval for Dupixent to treat moderate-to-severe atopic dermatitis in children aged between 6 months and 5 years.
Both REGN and SNY are also evaluating dupilumab in late-stage studies for a broad range of diseases, driven by type 2 inflammations like chronic obstructive pulmonary disease, bullous pemphigoid and prurigo nodularis indications among others.
Dupixent faces stiff competition from Xolair, a blockbuster drug, developed by Genentech, a Roche Group (RHHBY - Free Report) member, and Novartis (NVS - Free Report) to treat moderate-to-severe persistent asthma in patients aged 6 years and above. While Roche’s Genentech records all sales in the United States, Novartis records ex-U.S. sales of the drug. Additionally, Roche/Novartis’ Xolair is approved in the United States for nasal polyps and chronic spontaneous urticaria indications in the United States. The drug is also approved for these three indications in the EU.
Image: Bigstock
Regeneron (REGN), Sanofi's Dupixent Gets EU Nod for Asthma in Kids
Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the European Commission (EC) has approved the expanded use of their blockbuster drug Dupixent (dupilumab) in children aged 6-11 years with severe asthma.
With the label expansion approval, Dupixent becomes the only biologic approved in the European Union as an add-on maintenance therapy to treat severe asthma with type 2 inflammation in individuals aged six years and older. The severe asthma in such patients should be characterized by raised blood eosinophils (EOS) and/or raised fractional exhaled nitric oxide (FeNO).
The EC decision is based on data from the phase III LIBERTY ASTHMA VOYAGE study, which evaluated the efficacy and safety of Dupixent plus the standard-of-care asthma therapy (SOC) in children with uncontrolled moderate-to-severe asthma. The study pre-specified participants into two groups. The first group comprised patients with baseline blood EOS of at least 300 cells/μl and the second group consisted of patients either with baseline FeNO of at least 20 parts per billion or baseline blood EOS of at least 150 cells/μl.
Data from the study demonstrated that compared to placebo, the Dupixent-SOC combo substantially reduced asthma attacks by an average of 65% and 59% in the first and second groups, respectively. Participants in both groups administered with the Dupixent-SOC combo also showed improvements in lung function, asthma control and health-related quality of life compared to placebo.
Shares of Regeneron have risen 12.2% so far this year against the industry’s 12.1% decline.
Image Source: Zacks Investment Research
Sanofi’s stock has increased 8.1% in the year so far compared with the industry’s 7.4% rise.
Image Source: Zacks Investment Research
Dupixent is also approved by the FDA for a similar indication (asthma) for individuals aged six years and above. The drug received an approval for expanded use in the 6-11 years’ age bracket last October. The FDA nod was also based on data from the LIBERTY ASTHMA VOYAGE study.
Dupixent is jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with the global sales of the drug.For 2021, Dupixent generated global sales worth $6.2 billion, reflecting a 53% year-over-year rise.
Apart from asthma, Dupixent is approved to treat moderate-to-severe atopic dermatitis in patients aged six years and older, and for use with other medicines for maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled in the United States, Europe and some other countries.
Currently, Dupixent is the leading driver of growth for both Regeneron and Sanofi. Continued label expansion of the drug boosted both sales and profits, making it an important contributor to both companies.
Earlier this week, both Regeneron and Sanofi announced that the FDA accepted a supplemental biologics license application (sBLA), seeking label expansion of Dupixent (dupilumab) for eosinophilic esophagitis indication. The FDA’s decision is expected by Aug 3, 2022. Similarly, another verdict by the regulatory agency is expected by Jun 9, 2022, for another sBLA, which seeks an approval for Dupixent to treat moderate-to-severe atopic dermatitis in children aged between 6 months and 5 years.
Both REGN and SNY are also evaluating dupilumab in late-stage studies for a broad range of diseases, driven by type 2 inflammations like chronic obstructive pulmonary disease, bullous pemphigoid and prurigo nodularis indications among others.
Dupixent faces stiff competition from Xolair, a blockbuster drug, developed by Genentech, a Roche Group (RHHBY - Free Report) member, and Novartis (NVS - Free Report) to treat moderate-to-severe persistent asthma in patients aged 6 years and above. While Roche’s Genentech records all sales in the United States, Novartis records ex-U.S. sales of the drug. Additionally, Roche/Novartis’ Xolair is approved in the United States for nasal polyps and chronic spontaneous urticaria indications in the United States. The drug is also approved for these three indications in the EU.
Regeneron Pharmaceuticals, Inc. Price
Regeneron Pharmaceuticals, Inc. price | Regeneron Pharmaceuticals, Inc. Quote
Sanofi Price
Sanofi price | Sanofi Quote
Zacks Rank
Both Regeneron and Sanofi presently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.