Yahoo Finance Regeneron, SNY Win FDA Approval for a Broader Dupixent Label
Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has approved blockbuster drug Dupixent (dupilumab) for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP) for a broader population.
The regulatory body approved the drug as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP.
The latest approval expands the initial FDA approval (granted in June 2019) in CRSwNP for patients aged 18 years and older.
Regeneron’s shares have rallied 31.3% year to date compared to the industry’s growth of 0.5%.
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The company has a collaboration agreement with Sanofi SNY for Dupixent.
Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
Broader Label for SNY/REGN’s Dupixent
The FDA evaluated Dupixent for this expanded indication under Priority Review.
The approval is supported by data from two positive pivotal trials, SINUS-24 and SINUS-52, in adults with inadequately controlled CRSwNP. Data from the studies demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery at 24 weeks compared to placebo.
The approval is also supported by pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP, along with the safety data for Dupixent in adolescents aged 12 years and older with moderate-to-severe asthma.
CRSwNP, a chronic disease of the upper airway, driven in part by type 2 inflammation, obstructs the sinuses and nasal passages.
The disease affects approximately 9,000 adolescents in the United States.
Profits From Dupixent Boost REGN’s Top Line
Dupixent is already approved for certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria and chronic obstructive pulmonary disease in different age populations.
Regeneron and Sanofi are evaluating dupilumab in late-stage studies for chronic spontaneous urticaria (CSU), chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid.
The label expansion of Dupixent should increase its profit and boost REGN’s top line.
Sanofi and Regeneron recently announced encouraging data from the confirmatory phase III LIBERTY-CUPID C study evaluating Dupixent in CSU indication.
Sanofi and Regeneron plan to resubmit a regulatory filing before this year-end seeking label expansion for Dupixent in CSU indication.
Dupixent maintains its stellar performance and profits from this drug have helped REGN in offsetting the declining sales of its lead drug Eylea.
Eylea sales continue to be under pressure due to competition from Roche’s RHHBY Vabysmo. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The drug raked in CHF 1.8 billion in the first half of 2024 on strong demand in all regions.
Roche has already obtained FDA approval for Vabysmo prefilled syringe for people living with wet age-related macular degeneration, DME and retinal vein occlusion.
Zacks Rank
Regeneron 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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