FDA Approves Amgen's Uplizna As First Drug For Chronic Immune-Mediated Fibroinflammatory Disorder

The U.S. Food and Drug Administration (FDA) on Thursday approved Amgen Inc.’s (NASDAQ:AMGN) Uplizna (inebilizumab-cdon) as the first and only treatment for adult patients with Immunoglobulin G4-related disease (IgG4-RD).

IgG4-RD is a chronic immune-mediated fibroinflammatory disorder that often manifests with tumor-like masses and/or painless enlargement of multiple organs. 

This is the second approved indication for Uplizna, which the FDA previously approved for adult patients with AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) in June 2020.

Also Read: Amgen’s Uplizna Shows Improved Symptoms In Patients With Muscle Weakness Disorder Over One Year

The FDA also granted Uplizna Orphan Drug Designation for generalized myasthenia gravis (gMG). Regulatory filing activities are underway for gMG, and submission is anticipated to be completed in H1 2025.

The approval is supported by data from the MITIGATE trial. The trial demonstrated the potential of Uplizna to decrease disease activity by reducing flares in patients while maintaining its efficacy and established safety profile.

Key findings from the MITIGATE trial include:

• There was an 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period; 10.3% of participants receiving Uplizna experienced a flare compared to 59.7% of participants receiving placebo.
• 57.4% of participants receiving Uplizna achieved flare-free, treatment-free, and complete remission at Week 52 compared to 22.4% on placebo.
• 58.8% of participants receiving Uplizna achieved flare-free, corticosteroid-free, and complete remission at Week 52 compared to 22.4% on placebo.

Amgen Stock Prediction For 2025

Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.

Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at Amgen, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For Amgen, the 200-day moving average sits at $306.84, according to Benzinga Pro, which is below the current price of $309.85. For more on charts and trend lines, see a description here.

Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.

Price Action: AMGN stock is down 1.05% at $306.59 at the last check Friday.

Read Next:

• Brookfield Strikes $9 Billion Deal For Colonial Pipeline—Shell Offloads Minority Stake

Photo: Shutterstock/JHVEPhoto