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Sanofi's (SNY) Enjaymo Gets FDA Nod For Rare Blood Disorder
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Sanofi (SNY - Free Report) announced that the FDA has approved its monoclonal antibody, Enjaymo (sutimlimab-jome), to decrease the need for red blood cell transfusion due to hemolysis in adult patients with cold agglutinin disease (“CAD”), a rare blood disorder.
Following the nod, Enjaymo has become the first and only FDA-approved therapy for treating patients with CAD.
Patients with CAD experience complications like severe anemia and extreme fatigue. This is because the disease causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). Sutimlimab works by targeting C1-activated hemolysis in patients with CAD.
The FDA nod was based on positive data from the pivotal phase III CARDINAL study, which evaluated Enjaymo in patients with CAD who have a recent history of blood transfusion. Data from the 26-week study showed that treatment with Enjaymo led to an improvement in anemia as measured by hemoglobin and bilirubin levels in CAD patients.
Enjaymo met its primary efficacy endpoint in the study besides the secondary endpoints, which included improvements in hemoglobin and normalization of bilirubin.
Regulatory applications seeking approval for sutimlimab in Europe and Japan are currently under review. The FDA has already granted Breakthrough Therapy and Orphan Drug designation to Enjaymo for treating hemolysis in adult patients with CAD.
Shares of Sanofi have increased 7.1% in the past year compared with industry’s rise of 16.3%.
Image Source: Zacks Investment Research
In May 2020, the FDA granted priority review to the biologics license application (“BLA”) for sutimlimab to treat hemolysis in adult patients with CAD. A decision from the regulatory body was due on Nov 13, 2020.
However, the FDA issued a complete response letter (“CRL”) to the BLA for sutimlimab in November 2020. The CRL was issued due to certain deficiencies identified by the FDA during a pre-license inspection of a third-party manufacturing facility. The CRL did not mention any clinical or safety deficiencies in the BLA.
Finally, the FDA accepted the resubmission of the BLA for sutimlimab in October 2021. The FDA reviewed the BLA under priority review and set a target action date of Feb 5, 2020.
Sanofi plans to launch Enjaymo in the United States in the upcoming weeks. The price of Enjaymo is $1,800 per vial in the United States.The company’s rare blood disorders franchise recorded sales of €1.14 billion in 2021, down 3% year over year. The approval and subsequent launch of Enjaymo is likely to boost sales for the rare blood disorders franchise in 2022.
Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #5 (Strong Sell).
Image: Bigstock
Sanofi's (SNY) Enjaymo Gets FDA Nod For Rare Blood Disorder
Sanofi (SNY - Free Report) announced that the FDA has approved its monoclonal antibody, Enjaymo (sutimlimab-jome), to decrease the need for red blood cell transfusion due to hemolysis in adult patients with cold agglutinin disease (“CAD”), a rare blood disorder.
Following the nod, Enjaymo has become the first and only FDA-approved therapy for treating patients with CAD.
Patients with CAD experience complications like severe anemia and extreme fatigue. This is because the disease causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). Sutimlimab works by targeting C1-activated hemolysis in patients with CAD.
The FDA nod was based on positive data from the pivotal phase III CARDINAL study, which evaluated Enjaymo in patients with CAD who have a recent history of blood transfusion. Data from the 26-week study showed that treatment with Enjaymo led to an improvement in anemia as measured by hemoglobin and bilirubin levels in CAD patients.
Enjaymo met its primary efficacy endpoint in the study besides the secondary endpoints, which included improvements in hemoglobin and normalization of bilirubin.
Regulatory applications seeking approval for sutimlimab in Europe and Japan are currently under review. The FDA has already granted Breakthrough Therapy and Orphan Drug designation to Enjaymo for treating hemolysis in adult patients with CAD.
Shares of Sanofi have increased 7.1% in the past year compared with industry’s rise of 16.3%.
In May 2020, the FDA granted priority review to the biologics license application (“BLA”) for sutimlimab to treat hemolysis in adult patients with CAD. A decision from the regulatory body was due on Nov 13, 2020.
However, the FDA issued a complete response letter (“CRL”) to the BLA for sutimlimab in November 2020. The CRL was issued due to certain deficiencies identified by the FDA during a pre-license inspection of a third-party manufacturing facility. The CRL did not mention any clinical or safety deficiencies in the BLA.
Finally, the FDA accepted the resubmission of the BLA for sutimlimab in October 2021. The FDA reviewed the BLA under priority review and set a target action date of Feb 5, 2020.
Sanofi plans to launch Enjaymo in the United States in the upcoming weeks. The price of Enjaymo is $1,800 per vial in the United States.The company’s rare blood disorders franchise recorded sales of €1.14 billion in 2021, down 3% year over year. The approval and subsequent launch of Enjaymo is likely to boost sales for the rare blood disorders franchise in 2022.
Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #5 (Strong Sell).
Better-ranked stocks in the drug/biotech sector include Pfizer Inc. (PFE - Free Report) , Eli Lilly and Company (LLY - Free Report) and Zoetis Inc. (ZTS - Free Report) . While Pfizer sports a Zacks Rank #1 (Strong Buy), Eli Lilly and Zoetis carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Pfizer’s earnings estimates have been revised 39.6% upward for 2022 over the past 60 days. The stock has rallied 52.3% in the past year.
Pfizer’s earnings have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Eli Lilly’s earnings estimates have been revised 4.9% upward for 2022 over the past 60 days. The stock has surged 17.8% in the past year.
Eli Lilly’s earnings have surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Zoetis’ earnings estimates have been revised 0.6% upward for 2022 over the past 60 days. The stock has increased 24.7% in the past year.
Zoetis’ earnings have surpassed estimates in each of the trailing four quarters.