Pegloticase injecatble

Form: Injectable (IV solution)

Strength: 8 mg/1.2 mL vial

Reference Brands: Krystexxa (US)

Category: Arthritis

Pegloticase injectable is approved in the US for the treatment of severe, refractory gout unresponsive to conventional therapies. In the EU, it is not widely approved; primarily marketed in the US under the brand Krystexxa (by Horizon Therapeutics). Regulatory dossiers demonstrate safety, efficacy, and manufacturing quality supported by clinical trial data. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory submissions, compliance, and registration, visit PharmaTradz. We facilitate efficient market access for pegloticase, ensuring adherence to European and US standards for safe, effective management of refractory gout, helping clients navigate complex regulatory landscapes seamlessly.