AstraZeneca

FDA approves dupilumab for COPD, xanomeline and trospium chloride for schizophrenia, levacetylleucine for Niemann-Pick disease type C, FluMist for self-administered flu prevention, benralizumab for eosinophilic granulomatosis with polyangiitis, lebrikizumab-lbkz for atopic dermatitis, OTC hearing aid software for mild to moderate hearing loss, DaylightRX for generalized anxiety disorder, a disposable insulin patch pump for T1D and T2D, and an updated Novavax COVID-19 vaccine.

FDA approves Regeneron and Sanofi's Dupixent for COPD, making it the first biologic treatment for the condition. Dupixent, an interleukin-4 receptor alpha antagonist, showed reduced exacerbations and improved lung function in Phase III studies. The approval follows failures of GSK's Nucala and AstraZeneca's Fasenra in COPD trials.

Sanofi and Regeneron's Dupixent is the first biologic approved in the U.S. for COPD, potentially benefiting 300,000 adults with poorly controlled disease. Dupixent showed a 30-34% reduction in COPD exacerbations in Phase III studies and is consistent with existing safety profiles. The approval adds to Dupixent's list of FDA-approved indications, including asthma and eczema, with anticipated sales of $3.5 billion from the COPD approval. Competitors like GSK, AstraZeneca, and Amgen are also developing treatments for COPD.

FDA approves AstraZeneca's FluMist for self-administration, increasing seasonal flu vaccine accessibility and potential uptake. FluMist, a nasal spray vaccine, is approved for ages 2-49 and effective against influenza-associated complications. AstraZeneca plans to offer home delivery via a third-party online pharmacy starting in the 2025-26 season.

Elaine Sleigh, diagnosed with triple negative breast cancer in 2022, has returned to work after trialing the PETRA drug combination, which has kept her cancer at bay. The PETRA trial, sponsored by AstraZeneca, tests PARP inhibitor AZD5305, aiming to prevent cancer cells from repairing themselves.

AstraZeneca's Tagrisso (osimertinib) approved in the US for treating unresectable, Stage III EGFRm NSCLC, reducing disease progression risk by 84% compared to placebo. The approval is based on the LAURA phase III trial results, showing a median PFS of 39.1 months with Tagrisso versus 5.6 months for placebo. The trial continues to assess overall survival.

Fred Hutch Cancer Center study reveals a significant increase in U.S. cancer patients participating in industry-sponsored clinical trials compared to federally funded ones, highlighting underinvestment in federal studies and growing reliance on industry for cancer research.

Brexit and Kate Bingham's leadership secured early vaccine approvals, saving lives by immunizing vulnerable populations faster than EU countries.

FDA approves self-administered FluMist nasal spray vaccine for ages 2-49, aiming to boost seasonal flu vaccine uptake and accessibility.

FDA approves Tagrisso (osimertinib) for stage III unresectable NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, following CRT. Phase 3 LAURA trial showed median progression-free survival of 39.1 months with osimertinib vs 5.6 months with placebo (HR 0.16; 95% CI 0.10-0.24; P<.001).