Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved a label extension for the cholesterol drug Evkeeza.
The drug has now been approved as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).
It was initially approved as an adjunct to other lipid-lowering therapies in those aged 12 years and older with HoFH in February 2021.
HoFH, a severe form of familial hypercholesterolemia (FH), is an extremely-rare inherited condition that affects approximately 1,300 people in the United States.
48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in a phase III study.
The three-part, single-arm, open-label trial evaluated Evkeeza added to other lipid-lowering therapies in pediatric patients with HoFH aged 5 to 11 years. Part A (n=6) was a phase Ib study designed to assess the pharmacokinetics (PK), safety and tolerability of Evkeeza. Part B (n=14) evaluated the efficacy of Evkeeza during a 24-week treatment period and enrolled patients with an average age of 9 years. Among them, 86% were on statins, 93% were on ezetimibe, 50% were on LDL apheresis and 14% were on lomitapide. Patients received Evkeeza 15 mg/kg every four weeks delivered intravenously alongside their lipid-lowering treatment regimen. The primary endpoint was a change in LDL-C at week 24. Secondary endpoints included the effect of Evkeeza on other lipid parameters (i.e., apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein [a] and total cholesterol), efficacy by mutation status, safety and tolerability, immunogenicity and PK.
The FDA evaluated the supplemental biologics license for Evkeeza in this indication under Priority Review.
Label expansion of the drug will boost sales.
Regeneron’s shares have gained 13.7% in the past year against the industry’s decline of 14.2%.
Last month, the company reported better-than-expected fourth-quarter 2022 results even though lead drug Eylea (aflibercept) sales declined as Dupixent maintained its stellar performance with progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Eylea sales were negatively impacted by a short-term shift to off-label use of Avastin (bevacizumab), a temporary closing in the fourth quarter of 2022 of a not-for-profit fund that provides patient co-pay assistance and an increase in sales-related deductions.
While management believes that it has substantially recovered from the issue encountered in the fourth quarter, it continues to expect competitive pressures for Eylea.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Regeneron’s top line is also boosted by its share of profits/losses in connection with global sales of Dupixent. Dupixent is being jointly marketed by Regeneron and Sanofi (SNY - Free Report) under a global collaboration agreement.
Sanofi records the global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent maintains its dominant position in atopic dermatitis, asthma and nasal polyps and has been approved in new indications, geographies and younger populations.
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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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved a label extension for the cholesterol drug Evkeeza.
The drug has now been approved as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).
It was initially approved as an adjunct to other lipid-lowering therapies in those aged 12 years and older with HoFH in February 2021.
HoFH, a severe form of familial hypercholesterolemia (FH), is an extremely-rare inherited condition that affects approximately 1,300 people in the United States.
48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in a phase III study.
The three-part, single-arm, open-label trial evaluated Evkeeza added to other lipid-lowering therapies in pediatric patients with HoFH aged 5 to 11 years. Part A (n=6) was a phase Ib study designed to assess the pharmacokinetics (PK), safety and tolerability of Evkeeza. Part B (n=14) evaluated the efficacy of Evkeeza during a 24-week treatment period and enrolled patients with an average age of 9 years. Among them, 86% were on statins, 93% were on ezetimibe, 50% were on LDL apheresis and 14% were on lomitapide. Patients received Evkeeza 15 mg/kg every four weeks delivered intravenously alongside their lipid-lowering treatment regimen. The primary endpoint was a change in LDL-C at week 24. Secondary endpoints included the effect of Evkeeza on other lipid parameters (i.e., apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein [a] and total cholesterol), efficacy by mutation status, safety and tolerability, immunogenicity and PK.
The FDA evaluated the supplemental biologics license for Evkeeza in this indication under Priority Review.
Label expansion of the drug will boost sales.
Regeneron’s shares have gained 13.7% in the past year against the industry’s decline of 14.2%.
Last month, the company reported better-than-expected fourth-quarter 2022 results even though lead drug Eylea (aflibercept) sales declined as Dupixent maintained its stellar performance with progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Eylea sales were negatively impacted by a short-term shift to off-label use of Avastin (bevacizumab), a temporary closing in the fourth quarter of 2022 of a not-for-profit fund that provides patient co-pay assistance and an increase in sales-related deductions.
While management believes that it has substantially recovered from the issue encountered in the fourth quarter, it continues to expect competitive pressures for Eylea.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Regeneron’s top line is also boosted by its share of profits/losses in connection with global sales of Dupixent. Dupixent is being jointly marketed by Regeneron and Sanofi (SNY - Free Report) under a global collaboration agreement.
Sanofi records the global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent maintains its dominant position in atopic dermatitis, asthma and nasal polyps and has been approved in new indications, geographies and younger populations.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
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