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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Amgen’s humanised monoclonal antibody Uplizna (inebilizumab-cdon) to treat the adult population with immunoglobulin G4-related disease (IgG4-RD), an immune-mediated inflammatory condition that impacts several organs.
The trial was structured to assess the antibody against a placebo in minimising the flare risk in individuals with IgG4-RD. Credit: Diane Serik on Unsplash.
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This decision is based on the randomised MITIGATE trial data, which showed the antibody’s potential to reduce disease activity by minimising flares in individuals, upholding its established safety profile as well as efficacy.
The trial was structured to assess the antibody’s safety and efficacy against a placebo in minimising the flare risk in individuals with IgG4-RD.
Time to first treated and adjudicated IgG4-RD flare was the trial’s primary endpoint.
According to the company, the approval marks the second indication for the antibody.
In June 2020, the antibody gained approval from the US regulator for treating adults with aquaporin-4 immunoglobulin G positive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD).
It also secured orphan drug designation from the agency for treating generalised myasthenia gravis (gMG).
For the gMG indication, the company is expecting the regulatory submission of the antibody to be concluded in the first half of this year.
IgG4-RD can cause fibrosis and irreversible organ damage. Recognising the signs of organ damage is essential for the early diagnosis of this condition.
Amgen Research and Development executive vice-president Jay Bradner said: “The FDA approval of Uplizna marks a significant turning point for IgG4-RD patients and physicians who now have a proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use.
“We are proud to deliver a therapy that has the potential to significantly improve care for patients with IgG4-RD and remain encouraged by Uplizna’s broader potential in other immune-mediated diseases, including neuromyelitis optica spectrum disorder and gMG.”
