Shots:
- Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25
- The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and comparable safety & efficacy between ADL-018 and XOLAIR. Involving 600 pts, 400 received a confirmatory 300 mg dose Q4W for 24 wks. The primary efficacy measure was the change in weekly ISS7 at Wk. 12
- ADL-018 is a humanized mAb designed to block IgE binding to FcεR on mast cells and basophils, targeting CSU in patients 12+ with hives unresponsive to H1 antagonists
Ref: Businesswire| Image: Kashiv BioSciences & Amneal Pharmaceuticals | Press Release
Related News:- Gilead Sciences and Kymera Therapeutics Sign Exclusive Option and License Agreement to Develop Oral CDK2 Degraders
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
