Alexion’s Ultomiris (ravulizumab) Receives the CHMP’s Positive Opinion for its New Advanced Formulation

Shots:

• The CHMP has adopted a positive opinion recommending marketing authorization in the EU for a new 100 mg/mL (IV) advanced formulation of Ultomiris (ravulizumab). The positive opinion is based on CMC submission and a supplementary clinical data set showing that the safety, PK, and immunogenicity following administration of Ultomiris (10mg/mL & 100mg/mL) were comparable
• Results: no effect in efficacy measure of mean LDH; reduction in infusion time by more than half (1.3 to 3.3hrs.) & (0.4 to 1.3hrs.)  depending on the body weight, respectively. If approved, the new 100 mg/mL formulation will reduce infusion time by ~60%, lessening the burden on patients and health systems
• The company plans to submit regulatory filings in the US and EU in the Q3’21 for an Ultomiris (SC) and device combination for PNH and aHUS that can be self-administered at home, pending completion of the ongoing P-III study and collection of 12mos. safety data. Additionally, Alexion expands the clinical program of Ultomiris across hematology, nephrology, neurology, and for severe COVID-19, with 7 P-III programs that are ongoing or have planned clinical trial initiations in 2020

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