Amgen Inc (NASDAQ:AMGN), an American multinational biopharmaceutical company, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its UPLIZNA (inebilizumab-cdon) intended for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

The company says that the approval provides patients with a new targeted treatment option that has the potential for long-term disease control with just two doses per annum, after two initial loading doses.

UPLIZNA's approval for gMG is based on the data from the Myasthenia Gravis Inebilizumab Trial (MINT), claimed to be the largest Phase three biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a steroid taper into its protocol.

Richard J Nowak, MD, MS, global principal investigator and director of the Myasthenia Gravis Clinic at Yale University, said, "UPLIZNA showed strong efficacy at 26 weeks in both AChR+ and MuSK+ patients, with AChR+ patients continuing to improve through 52 weeks in MINT. MINT also uniquely required steroid tapering, recognising that long-term steroid use adds to the overall burden of disease. This approval brings a new first-in-class approach to gMG, expanding treatment options for clinicians and patients."

gMG is a rare, unpredictable, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness, trouble breathing, difficulty swallowing, and impaired speech and vision.