Amgen's muscular disorder drug meets main goal in late-stage study
By Bhanvi Satija and Puyaan Singh
(Reuters) -Amgen said on Tuesday that its drug helped improve daily activities including chewing and swallowing in patients suffering from a rare muscle-weakening disease, meeting the main goal of a late-stage study.
The company is testing its drug, inebilizumab or Uplizna, in patients suffering from myasthenia gravis, which is caused by an abnormal immune reaction that weakens the muscles that control the eyes, mouth, throat and limbs.
In the trial, patients receiving the drug showed an improvement of 4.2 points, or 1.9 when adjusted for placebo, on a commonly used scale for measuring disease impact on daily activities after 26 weeks.
Jefferies analyst Michael Yee said that the data was "a positive upside surprise" and came ahead of his expectations, especially given that the improvement in patients was seen after two doses.
Last year, the U.S. Food and Drug Administration approved Argenx SE's under-the-skin injection, Vyvgart Hytrulo, as a convenient treatment option for myasthenia gravis.
Engagement with regulatory bodies for Uplizna is underway for use in myasthenia gravis patients and for another immune system-related condition, said Amgen's chief scientific officer James Bradner on a call with analysts.
Uplizna - if approved for myasthenia gravis - will also compete with another treatment, Soliris by AstraZeneca.
Shares of the drugmaker fell over 2% to $323.64 in extended trading as it reported data from another experimental drug, rocatinlimab, that succeeded in a late-stage study in patients with atopic dermatitis or eczema.
About 33% of patients in the study showed a 75% or more improvement on an eczema severity index.
Results from this trial "appear to fall short" of already approved drugs like Eli Lilly's Ebglyss and Sanofi-Regeneron's blockbuster drug Dupixent, said BMO Capital Markets analyst Evan Seigerman.
Seigerman added that while a direct comparison was difficult, full data from Amgen's drug will be closely watched to assess its "competitive positioning."
(Reporting by Mariam Sunny, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Alan Barona and Shailesh Kuber)
