Here's How AMGN Benefits From FDA Nod to Uplizna in Myasthenia Gravis

Amgen AMGN announced that the FDA has approved its rare disease drug Uplizna (inebilizumab) for a new indication — generalized myasthenia gravis (gMG). The drug is approved to treat the disease in adults who have tested positive for anti-AChR or anti-MuSK antibodies.

With this approval, Uplizna is now the first CD19-targeted B-cell therapy approved for this patient population. Although many drugs are approved in the gMG space, the Amgen drug offers patients a twice-yearly dosing option — a significant advantage over existing therapies that require more frequent administrations.

The FDA’s decision is supported by data from the phase III MINT study, which showed strong efficacy benefits in gMG patients following treatment with Uplizna. gMG is an autoantibody-driven neuromuscular disease marked by fluctuating muscle weakness.

This marks the second approval for Uplizna this year and its third overall in the United States. In April, the drug became the first FDA-approved treatment for adults with a rare autoimmune disease called immunoglobulin G4-related disease (IgG4-RD). Uplizna is also approved for neuromyelitis optica spectrum disorder (NMOSD), another rare autoimmune disease.

The drug is part of Amgen’s rare disease franchise and was added to its portfolio following the acquisition of Horizon Therapeutics for nearly $28 billion in 2023. The approval strengthens Amgen’s presence in high-value autoimmune markets and expands the commercial potential of its rare disease portfolio.

Competition in the gMG Space

Post approval, Uplizna enters a highly competitive market for gMG therapies. Despite offering the key advantage of twice-yearly dosing, Amgen’s drug will compete directly with argenx’s ARGX Vyvgart/Vyvgart Hytrulo, J&J's JNJ Imaavy and Belgium-based UCB’s Rystiggo for market share.

While Vyvgart/Vyvgart Hytrulo is approved only for patients with anti-AChR positive antibodies, both Imaavy and Rystiggo — like Uplizna — are approved for patients who test positive for either anti-AChR or anti-MuSK antibodies. Notably, all three competing therapies from argenx, J&J and UCB share a common mechanism: they block the neonatal Fc receptor (FcRn) to treat gMG.

Another important distinction is age eligibility. While Amgen’s Uplizna, argenx’s Vyvgart/Vyvgart Hytrulo and UCB’s Rystiggo are approved only for adult patients, J&J’s Imaavy is approved for both adults and adolescents aged 12 years and older, potentially giving it a broader prescriber base.

AMGN’s Price Performance, Valuation and Estimates

Shares of Amgen have outperformed the industry year to date, as seen in the chart below.

From a valuation standpoint, Amgen is trading at a discount to the industry. Based on the price/earnings (P/E) ratio, the company’s shares currently trade at 14.67 times forward earnings compared to the industry's average of 16.59. The stock is trading above its five-year mean of 13.73.

EPS estimates for 2025 and 2026 have risen in the past 30 days.

Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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