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Regeneron (REGN), Sanofi Get Priority Review for Dupixent sBLA
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA has accepted for Priority Review the supplemental biologics license application (sBLA) seeking label expansion of blockbuster drug Dupixent (dupilumab)
The sBLA is seeking label expansion of the drug as an add-on maintenance treatment for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The agency has set a target action date of Jun 9, 2022.
The sBLA is supported by data from the phase III study evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged six months to five years with uncontrolled moderate-to-severe atopic dermatitis. The study met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone.
We note that the FDA has granted a Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in 2016 (in children aged six months to 11 years).
An approval will further boost the sales potential of this already successful drug, which raked in sales of $6.2 billion in 2021.
Upon approval, Dupixent will be the first biologic medicine available in the United States to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.
We note that Sanofi records global net product sales of Dupixent, and Regeneron records its share of profits/losses in connection with global sales of the drug.
Dupixent is already approved in the United States, Japan and other countries for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis and CRSwNP in different age populations. It is also approved in Europe for adults and adolescents aged 12 years and older as an add-on maintenance treatment for severe asthma.
Both the companies are working on expanding the drug’s label further. Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending to extend the approval of Dupixent in the European Union to include add-on maintenance treatment for children aged six to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide who are inadequately controlled on two maintenance therapies.
Shares of Regeneron have rallied 26.4% in the past year against the industry’s decline of 39.8%.
Image Source: Zacks Investment Research
Regeneron’s fourth-quarter results were strong with broad-based growth. Strong demand for Eylea and Dupixent maintained momentum for the company. Solid contribution from REGEN-COV has boosted the top line.
However, the lack of efficacy of REGEN-COV against the Omicron variant and the subsequent revision of the EUA will dent sales.
Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Vir Biotechnology (VIR - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Vir sports a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vir Biotechnology’s earnings per share estimates for 2022 have increased from $4.77 to $6.53 in the past 30 days. VIR beat estimates in two of the last four quarters, missing the same on the other two occasions, the average surprise being 12.95%.
The consensus estimate for 2022 earnings for Vertex has increased $1.01 over the past 60 days to $14.33. Shares of VRTX gained 16.1% in the past year.
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Regeneron (REGN), Sanofi Get Priority Review for Dupixent sBLA
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA has accepted for Priority Review the supplemental biologics license application (sBLA) seeking label expansion of blockbuster drug Dupixent (dupilumab)
The sBLA is seeking label expansion of the drug as an add-on maintenance treatment for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The agency has set a target action date of Jun 9, 2022.
The sBLA is supported by data from the phase III study evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged six months to five years with uncontrolled moderate-to-severe atopic dermatitis. The study met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone.
We note that the FDA has granted a Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in 2016 (in children aged six months to 11 years).
An approval will further boost the sales potential of this already successful drug, which raked in sales of $6.2 billion in 2021.
Upon approval, Dupixent will be the first biologic medicine available in the United States to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.
We note that Sanofi records global net product sales of Dupixent, and Regeneron records its share of profits/losses in connection with global sales of the drug.
Dupixent is already approved in the United States, Japan and other countries for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis and CRSwNP in different age populations. It is also approved in Europe for adults and adolescents aged 12 years and older as an add-on maintenance treatment for severe asthma.
Both the companies are working on expanding the drug’s label further. Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending to extend the approval of Dupixent in the European Union to include add-on maintenance treatment for children aged six to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide who are inadequately controlled on two maintenance therapies.
Shares of Regeneron have rallied 26.4% in the past year against the industry’s decline of 39.8%.
Regeneron’s fourth-quarter results were strong with broad-based growth. Strong demand for Eylea and Dupixent maintained momentum for the company. Solid contribution from REGEN-COV has boosted the top line.
However, the lack of efficacy of REGEN-COV against the Omicron variant and the subsequent revision of the EUA will dent sales.
Regeneron currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Vir Biotechnology (VIR - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Vir sports a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vir Biotechnology’s earnings per share estimates for 2022 have increased from $4.77 to $6.53 in the past 30 days. VIR beat estimates in two of the last four quarters, missing the same on the other two occasions, the average surprise being 12.95%.
The consensus estimate for 2022 earnings for Vertex has increased $1.01 over the past 60 days to $14.33. Shares of VRTX gained 16.1% in the past year.