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

Amgen Phase III Data Could Add Second Indication To Uplizna’s Label

 
• By Joseph Haas

Amgen’s study shows an 87% risk-reduction for IgG4-related disease flares, which can exacerbate the rare disorder and lead to irreversible organ failure. A US filing is planned.

Rare disease
Amgen's hopes Uplizna can become the first approved therapy for IgG4-RD • Source: Shutterstock

Amgen, Inc. could more than double the patient base for Uplizna (inebilizumab), currently approved to treat neuromyelitis optica spectrum disorder (NMOSD), with new Phase III data showing the antibody therapy can also treat patients with the rare immune-mediated disease immunoglobulin G4-related disease (IgG4-RD).

Key Takeaways

  • Uplizna may become the first approved therapy for IgG4-related disease after hitting its primary and three secondary endpoints in Phase III

  • Acquired in the 2022 Horizon buyout and already approved to treat neuromyelitis optic spectrum disorder, Uplizna is also being studied in myasthenia gravis

In the Phase III MITIGATE study, released 5 June, Uplizna reduced disease-related flares by 87% compared to placebo in the 52-week study (p<0

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

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

More from R&D

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.