FDA Approves Amgen's Drug For Rare Muscle Disorder

The U.S. Food and Drug Administration (FDA) on Thursday approved Amgen Inc.’s (NASDAQ:AMGN) Uplinza (inebilizumab-cdon) for generalized myasthenia gravis (gMG).

The approval covers adult patients who are anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

gMG is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness.

This is the third indication for Uplinza.

The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.

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The approval of Uplinza for gMG is supported by data from the Phase 3 MINT trial. Patients on steroids at baseline began tapering at Week 4 to reach prednisone 5 mg per day by Week 24.

By Week 26, 87.4% of patients taking Uplinza and 84.6% of those taking a placebo had reduced their steroid dose to 5 mg or less per day.6

At Week 26, Uplinza demonstrated a 1.9-point difference in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared with placebo (-4.2 vs. -2.2).

Price Action: AMGN stock is up 0.26% at $318.19 at the last check on Friday.

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