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Regeneron (REGN), Sanofi's Dupixent Succeeds in 2nd COPD Study
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced positive study data on the blockbuster asthma drug Dupixent from an interim analysis of the late-stage NOTUS study and other regulatory updates related to the drug.
The NOTUS trial evaluated the investigational use of Dupixent compared with placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (“COPD”) and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
This second late-stage study achieved its primary endpoint as Dupixent significantly reduced exacerbations by 34% compared with placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation.
Treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and was sustained at 52 weeks.
The results also reinforce positive results from the first late-stage BOREAS study, which showed that Dupixent demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared with placebo. Dupixent significantly improved quality of life, with numerical improvements as early as four weeks after initiating treatment.
Consequently, Regeneron and Sanofi plan to submit a supplemental biologics license application (“sBLA”) to the FDA by the end of 2023.
Please note that Regeneron and Sanofi’s application for the label expansion of Dupixent for the treatment of uncontrolled COPD with type 2 inflammation, based on results from the BOREAS trial, is currently under review in the European Union.
COPD damages lungs and causes progressive lung function decline.
A potential approval for the indication will further expand Dupixent’s broad label. The drug is already approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
The FDA previously granted Breakthrough Therapy designation to Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype based on the positive results from BOREAS.
Regeneron has a collaboration agreement with Sanofi for Dupixent. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Earlier this month, Regeneron delivered better-than-expected third-quarter 2023 results, even though the sales of its lead drug, Eylea, declined. Profits from Dupixent boosted the top line. Dupixent maintained its stellar performance, driven by continued solid demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
Dupixent’s uptake for the eosinophilic esophagitis indication has been strong and its demand is also robust for the prurigo nodularis indication. Additional label expansion of the drug will boost its sales.
Shares of REGN have gained 10.3% year to date against the industry’s decline of 22.9%.
Image Source: Zacks Investment Research
The FDA’s approval of a higher dose of its lead drug, Eylea (aflibercept), has also helped Regeneron combat the decline in Eylea sales due to competition from Roche’s (RHHBY - Free Report) Vabysmo.
The uptake of Roche’s Vabysmo has been outstanding. RHHBY has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo for these indications.
Regeneron currently carries a Zacks Rank #3 (Hold).
Ligand Pharmaceuticals’ 2023 earnings per share increased from $4.98 to $5.33 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.64.
Ligand beat earnings estimates in each of the last four quarters. The company delivered an earnings surprise of 67.19%, on average.
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Regeneron (REGN), Sanofi's Dupixent Succeeds in 2nd COPD Study
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced positive study data on the blockbuster asthma drug Dupixent from an interim analysis of the late-stage NOTUS study and other regulatory updates related to the drug.
The NOTUS trial evaluated the investigational use of Dupixent compared with placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (“COPD”) and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
This second late-stage study achieved its primary endpoint as Dupixent significantly reduced exacerbations by 34% compared with placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation.
Treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and was sustained at 52 weeks.
The results also reinforce positive results from the first late-stage BOREAS study, which showed that Dupixent demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared with placebo. Dupixent significantly improved quality of life, with numerical improvements as early as four weeks after initiating treatment.
Consequently, Regeneron and Sanofi plan to submit a supplemental biologics license application (“sBLA”) to the FDA by the end of 2023.
Please note that Regeneron and Sanofi’s application for the label expansion of Dupixent for the treatment of uncontrolled COPD with type 2 inflammation, based on results from the BOREAS trial, is currently under review in the European Union.
COPD damages lungs and causes progressive lung function decline.
A potential approval for the indication will further expand Dupixent’s broad label. The drug is already approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
The FDA previously granted Breakthrough Therapy designation to Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype based on the positive results from BOREAS.
Regeneron has a collaboration agreement with Sanofi for Dupixent. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Earlier this month, Regeneron delivered better-than-expected third-quarter 2023 results, even though the sales of its lead drug, Eylea, declined. Profits from Dupixent boosted the top line. Dupixent maintained its stellar performance, driven by continued solid demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
Dupixent’s uptake for the eosinophilic esophagitis indication has been strong and its demand is also robust for the prurigo nodularis indication. Additional label expansion of the drug will boost its sales.
Shares of REGN have gained 10.3% year to date against the industry’s decline of 22.9%.
Image Source: Zacks Investment Research
The FDA’s approval of a higher dose of its lead drug, Eylea (aflibercept), has also helped Regeneron combat the decline in Eylea sales due to competition from Roche’s (RHHBY - Free Report) Vabysmo.
The uptake of Roche’s Vabysmo has been outstanding. RHHBY has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo for these indications.
Regeneron currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Ligand Pharmaceuticals , which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand Pharmaceuticals’ 2023 earnings per share increased from $4.98 to $5.33 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.64.
Ligand beat earnings estimates in each of the last four quarters. The company delivered an earnings surprise of 67.19%, on average.