Novartis Terminates Clinical Development of Fevipiprant (AW039) in P-III LUSTER Studies for Patients with Uncontrolled GINA 4/5 Asthma

Shots:

• The P-III LUSTER-1 & 2 studies involve assessing of Fevipiprant (150/ 450mg) vs PBO in 894 & 877 patients aged ≥12yrs. in a ratio (1:1:1) with moderate-severe asthma, receiving GINA 4 and 5 SoC asthma therapy for 52wks. respectively
• The pooled analysis of P-III LUSTER 1 & 2 study did not support the further development of Fevipiprant for asthma as a primary indication, but it was well tolerated with AEs balanced across treatments groups
• Fevipiprant (qd) is an investigational, steroid-free therapy, act by blocking the DP2 pathway. Additionally, Novartis continues to invest in respiratory therapies with its respiratory portfolio including Xolair, Ultibro Breezhaler, QVM149

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