PERFORMING, SUPPORTING AND DELIVERING SCIENCE: IT’S WHAT WE DO

At Regeneron, we make medicines that help patients who are dealing with serious diseases. Two of the world’s top 10 leading medicines of 2022 were homegrown in Regeneron’s labs and collectively help millions of patients worldwide.

But we’re not done yet. With nine U.S. Food and Drug Administration (FDA) approved medicines and many exciting product candidates in the pipeline, we are only at the beginning of our journey to solve the human body’s most complex illnesses.

Male scientist working in a lab.

DELIVERING GROWTH — AND PROMISE — FOR PATIENTS

Using the power of science to repeatedly bring new medicines to patients is what we do at Regeneron. In 2022, we continued to reinforce our leadership in retinal disease with ongoing growth for EYLEA® (aflibercept) Injection and the promise of aflibercept 8 mg.

We presented new clinical data in Type 2 inflammatory diseases and expanded the use of Dupixent® (dupilumab) to five indications. We also shared new data from our emerging immuno-oncology portfolio and continued to deepen our research in genetics medicine.

“For our employees, Regeneron is a very special place to be. We are fueled by our amazing science and the medicines we bring to so many patients. Beyond that, it’s about the organization itself – our people and culture – that inspires us to be great together, every day.”

Headshot of Marion McCourt, Executive Vice President, Commercial.

Marion McCourt, Executive Vice President, Commercial

REGENERON’S HOMEGROWN AND FDA-APPROVED MEDICINES

LEARN MORE ABOUT OUR MEDICINES

ADVANCING OUR DISCOVERIES:
KEY REGULATORY UPDATES

(as of April 2023)

In 2022, our medicines reached millions of patients around the world, and through expanded indications and new regulatory approvals, our medicines have the potential to help millions more. These notable regulatory milestones occurred between January 2022 and April 2023.

This section contains submissions that are investigational and not yet approved by regulatory authorities. To view our approved products, including Prescribing Information, please click “Learn More About Our Medicines” above.

U.S. Food and Drug Administration (FDA)

Approved for atopic dermatitis (AD) in pediatrics (6 months to 5 years of age)

Approved for eosinophilic esophagitis (EoE) in adults and adolescents (12 years of age and older)

Approved for prurigo nodularis

Accepted for review the supplemental Biologics License Application (sBLA) for chronic spontaneous urticaria (CSU) in adults and adolescents (12 years of age and older)

European Commission (EC)

Approved for severe asthma in children (6 to 11 years of age)

Approved for EoE in adults and adolescents (12 years of age and older)

Approved for prurigo nodularis

Approved for severe atopic dermatitis in children (6 months to 5 years of age)

Japanese Ministry of Health, Labour and Welfare (MHLW)

Submitted regulatory application for AD in pediatrics and adolescence (6 months to 14 years of age)

Submitted regulatory application for prurigo nodularis

U.S. Food and Drug Administration

Approved for retinopathy of prematurity (ROP) in preterm infants

Granted pediatric exclusivity in connection with ROP study, extending period of EYLEA U.S. market exclusivity through May 17, 2024

European Commission

Approved for the treatment of ROP in preterm infants

Japanese Ministry of Health, Labour and Welfare

Approved for the treatment of ROP

AFLIBERCEPT 8 MG

U.S. Food and Drug Administration

Accepted for Priority Review the Biologics License Application (BLA) for wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and diabetic retinopathy

European Commission

Submitted regulatory application for wet AMD and DME

Aflibercept 8 mg is an investigational medicine for the indications listed here. The safety and efficacy of this drug candidate has not been fully evaluated by any regulatory authority for the disease categories indicated here.

U.S. Food and Drug Administration

Approved for the first-line treatment for advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy

European Commission

Approved for cervical cancer

Approved for first-line treatment of adults with advanced NSCLC with ≥1% PD-L1 expression

Japanese Ministry of Health, Labour and Welfare

Approved for cervical cancer

U.S. Food and Drug Administration

Approved for homozygous familial hypercholesterolemia (HoFH) in pediatrics (5 to 11 years of age)

U.S. Food and Drug Administration

Approved for polymyalgia rheumatica (PMR) in adults

POZELIMAB (REGN3918)

U.S. Food and Drug Administration

Accepted for Priority Review the BLA for CD55-deficient protein-losing enteropathy (CHAPLE) disease in adults and children (1 year of age and older)

Pozelimab (REGN3918) is an investigational medicine for the indication listed here. The safety and efficacy of this drug candidate has not been fully evaluated by any regulatory authority for the disease category indicated here.

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