1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Alexion’s Phase III Data Position Ultomiris For Expansion Into Myasthenia Gravis

 
• By Joseph Haas

As its acquisition by AstraZeneca moves toward closure, Alexion plans to file the Soliris follow-on for generalized myasthenia gravis in the US, EU and Japan. But potential competition awaits in the C5 inhibitor and FcRn antagonist classes.

Research scientist
Phase III data might put Alexion closer to adding myasthenia gravis to the Ultomiris label

Top-line Phase III data for Ultomiris in generalized myasthenia gravis (gMG) looked positive for Alexion Pharmaceuticals Inc. and its buyer, AstraZeneca PLC, but analysts wonder if another drug class might ultimately surpass complement 5 (C5) protein inhibitors in establishing a new standard of care.

Alexion reported on 16 July that its C5 inhibitor Ultomiris (ravulizumab) – a follow-on to Alexion’s rare disease blockbuster Soliris (eculizumab) – met statistical significance at 26 weeks of treatment on the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) patient assessment in a 175-patient, placebo-controlled study. For entry into the study, patients had to have an MG-ADL score of at least 6; at 26 weeks, treatment-arm patients’ scores were down an average of 3

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

More from R&D

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.