Binetrakin

Dupixent approved in China for COPD, based on phase 3 studies showing reduced exacerbations, improved lung function, and quality of life. COPD is a priority in China's Healthy China 2030 plan.

The FDA approved dupilumab (Dupixent) as the first biologic treatment for uncontrolled COPD with an eosinophilic phenotype, based on phase 3 trials showing reduced exacerbations and improved lung function.

Dupixent approved in China as the first biologic for COPD, following EU approval. Based on phase 3 studies, Dupixent significantly reduced exacerbations, improved lung function, and quality of life. COPD is a priority in China's Healthy China 2030 plan. Dupixent is now approved in four indications in China.

Medicenna Therapeutics Corp. announced the results of its annual shareholder meeting on September 26, 2024, where all nominees were elected as directors. Shareholders also voted for MNP LLP as the auditor. 45.89% of common shares were represented at the meeting.

FDA approves dupilumab for adolescents with chronic rhinosinusitis with nasal polyps, supported by SINUS-24 and SINUS-52 trials.

Sanofi and Regeneron's Dupixent recommended by CHMP for EoE in children aged 1-11 years, supported by phase 3 EoE KIDS trial results. Dupixent, already approved for EoE in older patients, targets IL-4 and IL-13 pathways and is also approved for multiple other conditions.

EMA's CHMP recommends Dupixent for EoE in children aged 1-11 years, supported by phase 3 EoE KIDS study showing histological remission and symptom improvement. Safety consistent with known profile. Pending EU approval.

Sanofi announced CHMP's positive opinion recommending Dupixent's expanded approval in the EU for eosinophilic esophagitis (EoE) in children aged 1 to 11 years. The recommendation is based on the EoE KIDS phase 3 study, showing Dupixent's efficacy in histological disease remission and safety consistent with its profile in adults and adolescents. The European Commission is expected to make a final decision soon.

The CHMP recommends Dupixent for EoE in children aged 1+ in the EU, pending EC approval. Dupixent, co-developed by Regeneron and Sanofi, showed significant histological remission in EoE KIDS Phase 3 trial. Regeneron's financial performance is strong, with Dupixent revenues surging 29% to $3.56 billion. Dupixent also received expanded FDA approval for chronic rhinosinusitis with nasal polyps in adolescents.

CHMP recommends EU approval of Dupixent for eosinophilic esophagitis in children aged 1-11 years, based on phase 3 study showing histological remission. If approved, it would be the first treatment for this age group in the EU.