AstraZeneca's Wainzua Recommended for EU Approval as New Therapy for Severe Asthma

In a significant development for asthma treatment, AstraZeneca announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its new therapy, Wainzua (inavolisib). The drug, designed to address severe asthma in adults, holds promise for individuals whose condition remains poorly controlled with currently available therapies. The European Commission will consider the CHMP recommendation and is expected to make a final decision within the coming months.

Wainzua specifically targets type 2 inflammation-driven asthma, a form associated with severe, persistent symptoms and significant impairment in quality of life. Patients with this type of asthma often rely on high doses of corticosteroids and may still experience frequent exacerbations, raising the need for more effective treatment options. By acting on this specific inflammatory pathway, Wainzua offers a targeted therapeutic approach to reduce exacerbations, lower corticosteroid use, and improve respiratory function.

Key Findings and Clinical Impact

In Phase III trials, Wainzua demonstrated remarkable results. Patients receiving Wainzua experienced a substantial reduction in exacerbations compared to those on standard care, as well as improved lung function and symptom control. The benefits observed in these studies underscore the potential of Wainzua to help patients regain control of their condition and enhance their overall quality of life.

Dr. Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “This CHMP recommendation underscores our commitment to advancing science and providing innovative solutions for chronic respiratory diseases. Wainzua has the potential to transform the lives of patients living with severe asthma, an area where unmet needs remain high.”

Anticipated Approval and Launch

Pending approval by the European Commission, Wainzua could be available to patients across the EU by early 2025. AstraZeneca is poised to work closely with healthcare systems across Europe to ensure Wainzua’s availability, with a strong emphasis on affordability and accessibility.

AstraZeneca’s success with Wainzua highlights the company's ongoing dedication to developing specialized treatments for chronic respiratory diseases. If approved, Wainzua will join AstraZeneca’s expanding portfolio of respiratory and immunology therapies, marking a significant advancement in the treatment of severe asthma and promising a new wave of relief for patients throughout Europe.