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

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

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

Click here ­to­ read full press release/ article | Ref: Alexion Image: Stat News

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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