Regeneron Pharmaceuticals

FDA expanded dupilumab's approval for chronic rhinosinusitis with nasal polyps to include adolescents aged 12-17, making it the only approved treatment for this age group. The approval was supported by phase III trials showing improvements in nasal congestion, polyp size, and sense of smell, and reduced need for corticosteroids or surgery. Adverse events more common with dupilumab include injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

Regeneron accuses Sandoz of patent infringement on Eylea and BPCIA violations, alleging Sandoz withheld critical info during biosimilar approval.

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.

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.

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, 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.

FDA expands Dupixent approval for adolescents (12-17) with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP), based on trials showing significant improvements in symptoms.

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.

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).