Amgen Inc. (NASDAQ: AMGN) announced that the U.S. FDA approved Uplizna (inebilizumab-cdon) for adult patients with anti-AChR and anti-MuSK antibody-positive generalized myasthenia gravis (gMG), marking the drug’s third approved indication.
Regulatory Milestone
Item
Details
Approval Date
11 Dec 2025
Agency
U.S. FDA
Product
Uplizna (inebilizumab-cdon)
New Indication
gMG patients with anti-AChR or anti-MuSK antibodies
Mechanism
CD19 B cell depleting antibody
Dosing
300 mg IV infusion every 6 months
Innovation
Third indication for Uplizna; first CD19-directed therapy for MuSK-positive gMG
Clinical Evidence & Safety Profile
Prior Indications
Approval Date
Population
NMOSD (AQP4‑positive)
June 2020
Neuromyelitis optica spectrum disorder
IgG4‑RD
April 2025
Immunoglobulin G4‑related disease
gMG (AChR/MuSK‑positive)
Dec 2025
~85% of generalized myasthenia gravis patients
Safety: Consistent with established profile; infusion reactions managed with premedication.
Market Opportunity & Competitive Landscape
Metric
Value
Context
US gMG Prevalence
20,000‑40,000 patients
~85% are AChR/MuSK‑positive
US gMG Market Size
$1.2 billion (2025)
Dominated by Soliris, Vyvgart, and Ultomiris
Uplizna Peak US Sales (gMG)
$300‑500 million by 2029
15‑20% market share in gMG segment
Competitive Advantage
CD19 depletion offers broad B‑cell knockdown
Differentiated vs. FcRn blockers
Global Expansion
Potential EU/Japan filings for gMG in 2026‑2027
Expands beyond US market
Licensing History & China Rights
Timeline
Event
May 2019
Hansoh Pharma (HKG: 3692) licenses inebilizumab from Viela Bio for mainland China, Hong Kong, Macau
2021
Viela Bio acquired by Horizon Therapeutics
2023
Horizon acquired by Amgen; rights transfer complete
Expected Filing
Hansoh to submit gMG NDA in China by 2026
Forward‑Looking Statements This brief contains forward‑looking statements regarding Uplizna’s market penetration, competitive positioning, and global expansion. Actual results may differ due to pricing negotiations, payer coverage decisions, and competitive responses from FcRn and complement inhibitors.-Fineline Info & Tech
By Fineline Cube 