NovelMed’s NM5072 Receives the US FDA’s Orphan Drug Designation to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)
Shots:
- The US FDA has granted orphan drug designation to the company’s NM5072, first-in-class monoclonal antibody, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)
- The drug concluded P-I study in healthy participants (n=48) showing a well-tolerated & favorable safety profile at all dosing up to 20mg/kg and AP inhibition demonstrating a dose-dependent response
- The company anticipates the P-II clinical evaluation of NM5072 in treatment-naïve patients with paroxysmal nocturnal hemoglobinuria and is being reviewed for other indications such as C3G & aHUS. The SC formulation is planned for upcoming trials
Ref: Globenewswire | Image: NovelMed
Related News:- Novartis Reports US FDA’s Approval of Fabhalta (iptacopan) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
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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.
