NATIONAL JEWISH HEALTH

Tezepelumab Shows 79% Reduction in Severe Asthma Exacerbations in Real-World Study

3 months ago

• Phase 4 PASSAGE study demonstrates tezepelumab reduced annualized asthma exacerbation rates by 79% in real-world patients with severe asthma after 6 months of treatment. • The study included diverse patient populations often excluded from clinical trials, including those with COPD and smoking history, with significant benefits observed regardless of perennial allergy status. • Emergency department visits and hospitalizations decreased dramatically, with up to 95% reduction in patients with clinically relevant perennial allergies and 77% in those without.

Enveda's AI-Driven Natural Product Candidate ENV-294 Enters Phase I for Atopic Dermatitis

6 months ago

• Enveda's ENV-294, a novel oral anti-inflammatory agent derived from nature using AI, has entered Phase I clinical trials for atopic dermatitis and other inflammatory conditions. • The FDA has cleared the IND application for ENV-294, which has shown robust efficacy and high safety margins in preclinical studies. • Enveda's AI platform accelerates the discovery of natural product-based medicines, potentially offering safer and more effective alternatives to existing treatments for eczema. • ENV-294 is also being considered for asthma treatment, targeting key inflammatory pathways with a non-steroidal, orally delivered therapeutic.

FDA Approves Novel Therapies for Frostbite, Food Allergies, and Synovial Sarcoma in 2024

7 months ago

• The FDA approved Aurlumyn (iloprost) in February 2024, the first-ever treatment for severe frostbite, significantly reducing the risk of amputation in affected patients. • Omalizumab (Xolair) received FDA approval in February 2024 to reduce allergic reactions following accidental food exposure, benefiting individuals with life-threatening food allergies. • Tecelra, a T-cell receptor gene therapy, was approved in August 2024 for metastatic synovial sarcoma, marking a significant advancement in treating this rare cancer. • The FDA has authorized 950 AI/ML-enabled medical devices, including 21 in 2024, showing progress in integrating artificial intelligence into healthcare for improved diagnostics and treatments.

Fasenra Receives FDA Approval for Eosinophilic Granulomatosis with Polyangiitis

8 months ago

• The FDA has approved AstraZeneca's Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). • The approval was based on the Phase III MANDARA trial, which demonstrated non-inferiority to mepolizumab in achieving remission. • Fasenra showed a significant proportion of patients could taper off oral corticosteroids, offering a crucial benefit. • This approval marks Fasenra as only the second biologic approved for EGPA, providing a new treatment option for this rare disease.