Amgen's Uplizna Meets Primary Endpoint in Late-Stage Myasthenia Gravis Trial, Files for Regulatory Approval

Gelonghui September 25 | Amgen announced that its drug inebilizumab, or Uplizna, for the treatment of rare myasthenia gravis, has met the primary endpoint in a late-stage study. Myasthenia gravis is caused by an abnormal immune response that weakens the muscles controlling the eyes, mouth, throat, and limbs. In the trial, patients treated with the drug showed a 4.2-point improvement on a commonly used scale measuring the disease's impact on daily activities after 26 weeks, or 1.9 points after placebo adjustment. Jefferies analyst Michael Yee described the data as a "positive upside surprise," exceeding his expectations. Amgen's Chief Scientific Officer James Bradner stated during a conference call with analysts that discussions are ongoing with regulatory authorities to use Uplizna for treating myasthenia gravis patients and another immune system-related condition. If Uplizna is approved, it will compete with another treatment drug—AstraZeneca's Soliris.