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Sanofi (SNY), Regeneron Dupixent Gets CHMP Nod for Skin Disease
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Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the approval of Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, a chronic inflammatory skin disease.
The European Commission is expected to give its decision for the expanded use in the coming months. If approved in Europe, Dupixent became the first-and-only treatment to be approved for prurigo nodularis in the country. The CHMP’s recommendation was based on data from two phase III studies, PRIME and PRIME2, which evaluated the safety and efficacy of Dupixent in adults with prurigo nodularis. Data from the studies showed that Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with prurigo nodularis.
In Europe, Dupixent is presently approved to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
The FDA approved Dupixent for prurigo nodularis in September. Prurigo nodularis was the fifth FDA-approved disease indication for Dupixent in the United States. Dupixent is now approved in the United States for five type II inflammatory diseases, namely severe CRSwNP, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Sanofi stock has risen 14.6% this year so far compared with the industry’s increase of 2.9%.
Image Source: Zacks Investment Research
Dupixent is being 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.
Dupixent sales are now annualizing at close to €9.0 billion in sales after around five years on the market. Sanofi expects Dupixent to achieve more than €13 billion in peak sales. The drug’s frequent label expansion approvals are driving the drug’s sales higher. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are expected to be higher.
Dupixent has become the key driver of the top line for Sanofi. Dupixent generated global product sales of $5.9 billion in the first nine months of 2022, which were recorded by Sanofi.
Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases, driven by type II inflammation like bullous pemphigoid, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
Vertex Pharmaceuticals’ stock has risen 38.1% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while those for 2023 have increased from $15.10 to $15.60 per share over the past 30 days.
Vertex has a four-quarter earnings surprise of 3.16%, on average.
Bayer’s stock is down 1.7% this year so far. Earnings of Bayer beat estimates in three of the last four quarters, the average surprise being 18.23%. Earnings estimates for 2022 have risen from $2.02 to $2.03 per share in the past seven days.
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Sanofi (SNY), Regeneron Dupixent Gets CHMP Nod for Skin Disease
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the approval of Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, a chronic inflammatory skin disease.
The European Commission is expected to give its decision for the expanded use in the coming months. If approved in Europe, Dupixent became the first-and-only treatment to be approved for prurigo nodularis in the country. The CHMP’s recommendation was based on data from two phase III studies, PRIME and PRIME2, which evaluated the safety and efficacy of Dupixent in adults with prurigo nodularis. Data from the studies showed that Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with prurigo nodularis.
In Europe, Dupixent is presently approved to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
The FDA approved Dupixent for prurigo nodularis in September. Prurigo nodularis was the fifth FDA-approved disease indication for Dupixent in the United States. Dupixent is now approved in the United States for five type II inflammatory diseases, namely severe CRSwNP, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Sanofi stock has risen 14.6% this year so far compared with the industry’s increase of 2.9%.
Image Source: Zacks Investment Research
Dupixent is being 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.
Dupixent sales are now annualizing at close to €9.0 billion in sales after around five years on the market. Sanofi expects Dupixent to achieve more than €13 billion in peak sales. The drug’s frequent label expansion approvals are driving the drug’s sales higher. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are expected to be higher.
Dupixent has become the key driver of the top line for Sanofi. Dupixent generated global product sales of $5.9 billion in the first nine months of 2022, which were recorded by Sanofi.
Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases, driven by type II inflammation like bullous pemphigoid, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Some better-ranked large drugmakers include Vertex Pharmaceuticals (VRTX - Free Report) and Bayer (BAYRY - Free Report) , each of which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ stock has risen 38.1% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while those for 2023 have increased from $15.10 to $15.60 per share over the past 30 days.
Vertex has a four-quarter earnings surprise of 3.16%, on average.
Bayer’s stock is down 1.7% this year so far. Earnings of Bayer beat estimates in three of the last four quarters, the average surprise being 18.23%. Earnings estimates for 2022 have risen from $2.02 to $2.03 per share in the past seven days.