Astria Therapeutics’ Navenibart Gains the US FDA’s Orphan Drug Designation to Treat Hereditary Angioedema
Shots:
- The US FDA has granted orphan drug designation to the company’s navenibart (STAR-0215) for the treatment of hereditary angioedema (HAE)
- Navenibart was being assessed under the P-Ib/II (ALPHA-STAR) study that depicted favorable safety & tolerability as well as monthly attack rates reduction by 90-96% with once or twice over 6mos. dosing. This data will form the basis of P-III study planned during Q1’25, with topline data by the YE’26
- Navenibart (STAR-0215) is a best-in-class mAb that works by inhibiting kallikrein and is developed to offer long-acting, safe & effective attack prevention for HAE with Q3M/Q6M dosing
Ref: Astria Therapeutics | Image: Astria Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
