Regeneron Pharmaceuticals

FDA approves Dupixent for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps, expanding its initial 2019 approval for adults.

The FDA approved dupilumab (Dupixent) as add-on maintenance therapy for 12-17-year-olds with chronic rhinosinusitis with nasal polyposis (CRSwNP), expanding its age range following the 2019 approval for adults. Dupilumab, a monoclonal antibody targeting IL-4 and IL-13 pathways, is not an immunosuppressant. This approval follows positive phase 3 data and long-term efficacy findings in CRSwNP patients.

FDA approves J&J's Tremfya for ulcerative colitis; Novo Nordisk's amycretin shows faster weight loss than Wegovy; Dupixent improves disease remission in bullous pemphigoid study.

A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.

Dupixent (dupilumab) showed significant potential in treating chronic spontaneous urticaria (CSU) in biologic-naïve patients unresponsive to antihistamines, reducing itch and urticaria activity scores by 50% compared to placebo in the LIBERTY-CUPID Study C. The safety profile of Dupixent remained consistent with previous findings, and the study results are expected to be submitted to the FDA by the end of the year.

Sanofi and Regeneron’s Dupixent approved by MHRA as add-on treatment for uncontrolled COPD in UK, reducing exacerbations and improving lung function.

Regeneron Pharmaceuticals' PE, PB, and PS ratios are low, suggesting potential undervaluation. However, its low ROE indicates lower profitability. High EBITDA and gross profit levels indicate strong financial performance, but low revenue growth may be a concern.

Sanofi and Regeneron plan to resubmit an FDA application for Dupixent in chronic spontaneous urticaria (CSU) by year-end, after a trial showed a 50% reduction in itch and urticaria activity scores. The companies also announced positive results in bullous pemphigoid and plan to seek U.S. approval for this indication. Despite challenges, Dupixent is used by 1 million patients across seven indications, with Japan being the first to approve it for CSU.

Phase 3 LIBERTY-CUPID Study C for dupilumab in chronic spontaneous urticaria (CSU) met primary and secondary endpoints, showing dupilumab significantly reduced itch and hives compared to placebo. Dupilumab achieved a 30% complete response rate versus 18% for placebo by week 24, with equivalent adverse event rates. These results support dupilumab's potential as a targeted therapy for CSU, pending FDA approval.

Sanofi and Regeneron's Dupixent meets success criteria in Phase III study for bullous pemphigoid.