Our
Medicines

Video of Dan and Bola about making medicines.

Pushing the boundaries of science to discover, develop and deliver life-changing medicines

We make medicines that address serious medical conditions across multiple therapeutic areas. Our nine FDA-approved medicines are only the beginning of our quest to solve the human body's most complex mysteries and positively impact lives.

Regeneron-Invented FDA-Approved Medicines

Commercialized by Kiniksa Pharmaceuticals,
Ltd. in U.S.

Commercialized with Sanofi.

Commercialized by Regeneron in the U.S. and Ultragenyx Pharmaceuticals Inc. outside U.S.

Commercialized by Regeneron in U.S. and Bayer outside U.S.

Commercialized with Sanofi.

Commercialized by Regeneron in U.S. and Sanofi outside U.S.

Commercialized by Sanofi.

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About our medicines

advancing our medicines in 2021:
key regulatory updates

In 2021, our medicines reached more people than ever through expanded indications and new regulatory approvals. These regulatory milestones occurred between January 2021 and April 2022.
Investigational indications not yet approved by health authorities or regulatory agencies.

EYLEA (aflibercept) Dupixent (dupilumab) Libtayo (cemiplimab-rwlc) REGEN-COV
(casirivimab and imdevimab) Evkeeza (evinacumab) Praluent (alirocumab)

EYLEA (aflibercept)

TRAP

Submitted regulatory application to the European Commission (EC) for retinopathy of prematurity

Dupixent (dupilumab)

IL-4R antibody

U.S. Food and Drug Administration (FDA) Approved for asthma in pediatrics (6-11 years of age) Approved for 200 mg auto-injector Accepted for priority review the Supplemental Biologics License Application (sBLA) submission for infant and young children (6 months - 5 years) with atopic dermatitis (target action date of June 9, 2022)

Accepted for priority review the sBLA for eosinophilic esophagitis (EoE) (target action date of August 3, 2022)

European Commission (EC) Approved for severe asthma with type 2 inflammation who are inadequately controlled on two maintenance therapies in pediatrics (6-11 years of age) Submitted regulatory application for infant and young children (6 months - 5 years) with atopic dermatitis

Libtayo (cemiplimab-rwlc)

PD-1 inhibitor

U.S. Food and Drug Administration (FDA)
European Commission (EC) Approved by the FDA and EC for first-line treatment of advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression as a monotherapy Approved by the FDA and EC for advanced basal cell carcinoma (BCC)

Approved by Health Canada in second-line cervical cancer Withdrew the sBLA for cervical cancer Submitted regulatory applications for NSCLC chemotherapy combination to the FDA and EC Submitted regulatory application for cervical cancer to the EC

REGEN-COV
(casirivimab and imdevimab)

antibody cocktail
Known as Ronapreve outside the U.S.

Approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for COVID-19 treatment and post-exposure prophylaxis Approved by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and European Commission to prevent and treat COVID-19

Approved by EC to treat non-hospitalized patients and to prevent COVID-19; submitted regulatory application to the EC for treatment of hospitalized patients The FDA granted an EUA for treatment and post-exposure prophylaxis of COVID-19; the FDA later amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a non-susceptible SARS-CoV-2 variant (Omicron B.1.1.529)

In April 2022, the FDA extended review of the BLA to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals (target action date of July 13, 2022)

Evkeeza (evinacumab)

ANGPTL3 inhibitor

U.S. Food and Drug Administration (FDA)
European Commission (EC) Approved by the FDA and EC for homozygous familial hypercholesterolemia (HoFH) Established license and collaboration agreement with Ultragenyx Pharmaceutical Inc. to clinically develop, commercialize and distribute outside of U.S.

Praluent (alirocumab)

PCSK9 inhibitor

U.S. Food and Drug Administration (FDA) Approved by the FDA as add-on treatment for homozygous familial hypercholesterolemia (HoFH)

next: making our medicines

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Bola Akinlade, MD, FACP, Senior Vice President, Clinical Development, Immunology and Inflammation: It's really, really cool what you guys in IOPS are doing. You've got to manage a lot of the marketed stuff and also manage what's in the pipeline in terms of your clinical trials. How do you juggle such a large number of products that you have to manufacture for us?

Daniel Van Plew, Executive Vice President, Industrial Operations and Product Supply: We have built particularly the Rensselaer operations so that they're very good at receiving new processes and getting them into early launch. So this whole system was really built with that expectation that we would have a lot of molecules.

Bola: Some of our studies were impacted by COVID but we found ways around. We had to send drug to patients at home. We were doing everything we can, and a lot of credit to the team to come up with innovative ways to ensure the trials continued.

Daniel: We were able to keep our filling plant on track, which was not easy, and it was a mix of onsite and offsite. And the other thing is things happen in real time. You know, you're in the middle of a run. You don't have the ability to say, "Hey, let's talk about this next week." You might have three hours over which you have to resolve something. And that made it challenging too. I would say it was literally a heroic effort on the team's part.

Bola: I'm most proud of the team being able to accomplish so much despite the pandemic. For Dupixent, for example, we were able to get lots of regulatory approvals that actually would impact a lot of patients. We now have six diseases that Dupixent has shown efficacy in. I mean, that's amazing for one particular drug.

Daniel: Dupixent's just, you know, such a powerful motivator for people because they believe in it. They know it works. They see it growing. And it's just really cool.

Bola: I'm going to tell you a story. Some people that deal with the public received a note from someone whose dad was on Dupixent. This person wrote to the company saying, "I would like to thank the people who developed Dupixent, okay? Because this drug has changed my father's life." They were able to set up a meeting with the Dupixent team and surprised the dad and said, "This was what your son asked for as a holiday present for you."

Daniel: In my space, you always want to have that emotional tie between the workers and the drugs that they're making because my organization is the only part of the company that touches drug going into people. So having people have an emotional tie to it is so important. And as those stories came in, just the pride and the commitment that people showed to get this done which, by the way, plays into how we pulled it all off too. You know, the emotional tie to this was so, so strong for so many people.

Bola: You know, we talk about the Regeneron sauce, secret sauce, the magic. I think the magic lies in the people that work at Regeneron. You know, the COVID pandemic showcased how quickly Regeneron was able to apply its incredible science to actually addressing a scourge that most people have never seen before.

Daniel: Now, the collaborations, I think they're very, very powerful, sometimes in ways you don't anticipate.

Bola: Of course, this is Regeneron. We don't know when the next pandemic is going to come up. We don't know what it's going to be like but I can tell you that our scientists, okay, are already on the ready to address any emerging new conditions or new diseases 'cause we have the technology to do it. This is Regeneron.

Our Medicines

Regeneron-Invented FDA-Approved Medicines

advancing our medicines in 2021:key regulatory updates

Our
Medicines

advancing our medicines in 2021:
key regulatory updates