Regeneron Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1988-01-01
- Employees
- 13.4K
- Market Cap
- $132.4B
- Website
- http://www.regeneron.com
- Introduction
Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, George Damis Yancopoulos, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.
Sanofi/Regeneron's Dupixent granted FDA approval for adolescents with CRSwNP
Sanofi and Regeneron’s Dupixent approved by FDA as add-on maintenance treatment for adolescents with chronic rhinosinusitis with nasal polyps (CRSwNP), ages 12-17, expanding previous approval for ages 18 and older. Dupixent, a monoclonal antibody, inhibits interleukin-4 and interleukin-13 pathways, improving symptoms and reducing need for systemic corticosteroids or surgery.
New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds
FDA approves Eli Lilly's Ebglyss (lebrikizumab) for moderate-to-severe atopic dermatitis, offering once-monthly dosing. Ebglyss targets IL-13, providing clear skin in 38% of patients at 16 weeks, compared to 12% with placebo. Common side effects include eye inflammation, injection site reactions, and shingles.
Dupixent gains FDA approval for expanded use in adolescents with CRSwNP
Regeneron Pharmaceuticals and Sanofi receive FDA approval for Dupixent as add-on treatment for adolescents with CRSwNP, based on Phase 3 trials showing improvements in nasal congestion, polyp size, and sense of smell, and reduced need for corticosteroids or surgery.
Regeneron's melanoma combo therapy benefit continues beyond two years
Regeneron's melanoma combo therapy, fianlimab plus Libtayo, shows 25% complete response and 57% objective response rates after 23 months in a Phase I trial, with ongoing Phase III studies.
Related Clinical Trials:
Dupixent receives FDA approval as first CRSwNP treatment
FDA expands Dupixent approval for adolescents (12-17) with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP), based on trials showing significant improvements in symptoms.
KEYNOTE-006 Study of Pembrolizumab Shows Continued Survival Benefits in Advanced Melanoma
Pembrolizumab (Keytruda) showed sustained survival benefits over ipilimumab (Yervoy) in unresectable stage III or IV melanoma patients, with 10-year follow-up data from the KEYNOTE-006 study presented at the 2024 ESMO Congress. Pembrolizumab had a median overall survival (OS) of 32.7 months vs 15.9 months for ipilimumab, with 8- and 10-year OS rates of 36.9% and 34.0% vs 24.8% and 23.6%, respectively. The study also highlighted the safety profile and long-term efficacy of pembrolizumab, supporting its standard of care status in advanced melanoma.
Related Clinical Trials:
FDA Action Alert: BMS, Merck, Sanofi/Regeneron and More
FDA decision deadlines include Vanda's tradipitant for gastroparesis (Sept 18), Zevra's arimoclomol for Niemann-Pick disease type C (Sept 21), Heron's extended-release needle for Zynrelef (Sept 23), Merck's Keytruda for pleural mesothelioma (Sept 25), and Bristol Myers Squibb's KarXT for schizophrenia (Sept 26). Sanofi and Regeneron await FDA verdict on Dupixent for COPD (Sept 27).
Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents
FDA approves Dupixent for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), expanding from initial approval for adults. Dupixent, a biologic inhibiting IL-4 and IL-13 pathways, demonstrated efficacy in trials, improving nasal congestion, polyp size, and sense of smell, while reducing corticosteroid use and surgery.
LIBERTY-CUPID Study C Confirms Benefit of Dupilumab in Biologic-Naive CSU
LIBERTY-CUPID Study C confirms dupilumab's efficacy in reducing itch and disease activity in uncontrolled chronic spontaneous urticaria (CSU) patients. Dupilumab met primary and key secondary endpoints, with a 30% complete response rate in dupilumab-treated patients compared to 18% in the placebo group. Safety results were consistent with dupilumab's known profile, and Sanofi plans to share these data with the FDA to support an sBLA for CSU treatment.
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