Bio-Thera Reports First Patient Dosing in P-I Study of BAT2606, a Proposed Biosimilar of Nucala (mepolizumab) for Severe Asthma
Shots:
- The first has been dosed in the P-I study to evaluate the PK and safety of BAT2606 vs US & EU-sourced Nucala in 207 healthy volunteers with severe asthma
- The company also plans to initiate the P-III study & requested approval for all available indications when filing the BLA/MAA with NMPA, FDA, EMA, and other regulatory bodies globally
- Mepolizumab is an interleukin-5 (IL-5) antagonist mAb, given as SC with a syringe or autoinjector. The therapy is indicated for severe asthma & eosinophilic phenotype in adult and pediatric patients aged ≥6yrs., chronic rhinosinusitis with nasal, eosinophilic granulomatosis with polyangiitis & hypereosinophilic syndrome
Ref: Buisnesswire | Image: Bio-Thera
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