<div id="readability-page-1">04:29 AM EST, 12/12/2025 (MT Newswires) -- Amgen ( AMGN ) said late Thursday the US Food and Drug Administration approved Uplizna to treat adults with generalized myasthenia gravis, who test positive for certain related antibodies.The label includes twice-yearly dosing after two starter doses, and it is backed by results from a phase 3 study.Uplizna showed a 1.9-point difference versus placebo on a daily activities symptom score at week 26, and the benefits in antibody-positive patients continued through week 52, Amgen ( AMGN ) said.The most adverse side effects in the trial were headache and infusion-related reactions, according to the company.Generalized myasthenia gravis is a rare autoimmune disorder that causes fluctuating neuromuscular weakness. MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.</div>

AMGN

Amgen announced that the FDA has approved Uplizna for the treatment of adults with generalized myasthenia gravis who test positive for specific antibodies. The treatment involves twice-yearly dosing after initial doses and is supported by phase 3 study results. Uplizna showed significant improvement in symptoms compared to placebo, with benefits lasting up to 52 weeks. Common side effects included headache and infusion-related reactions.

Amgen Says FDA Approves Uplizna For Autoimmune Disorder Treatment