Amgen (NASDAQ: AMGN) receives FDA approval of UPLIZNA

Shares of Amgen Inc (NASDAQ: AMGN) climbed 1.4% today after the company announced that the U.S. Food and Drug Administration (FDA) has approved its drug UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD). This approval positions UPLIZNA as the first and only FDA-approved treatment for this chronic and potentially debilitating condition, which can affect multiple organs and lead to irreversible damage.

The FDA’s decision to grant Breakthrough Therapy Designation to UPLIZNA underscores the significant unmet medical need in IgG4-RD, a disease characterized by immune-mediated inflammatory flares that can mimic other conditions. The approval is based on results from the MITIGATE trial, which demonstrated UPLIZNA’s ability to decrease disease activity by reducing flares while maintaining an established safety profile.

Jay Bradner, M.D., executive vice president of Research and Development at Amgen, expressed the company’s pride in delivering a therapy that significantly improves care for patients with IgG4-RD. He emphasized UPLIZNA’s potential in treating other immune-mediated diseases and Amgen’s commitment to developing innovative treatments targeting CD19+ B-cells.

John Stone, M.D., M.P.H., the principal investigator of the MITIGATE trial and a professor at Harvard Medical School, highlighted the effectiveness of targeting CD19+ B cells with UPLIZNA in addressing the pathophysiology of IgG4-RD. He pointed out the importance of raising disease awareness to ensure patients receive the right treatment early in their diagnostic journey.

This approval marks the second indication for UPLIZNA, which was previously approved for the treatment of adult patients with AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) in June 2020. The FDA has also granted the drug Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG), with regulatory filing activities for gMG expected to be completed in the first half of 2025.

Citi analyst Geoff Meacham reiterated a Neutral rating and a $295.00 price target on Amgen. He commented on the recent FDA approval, stating, “We think this approval likely adds incremental growth to Uplizna revenues (2025e $516M BBG cons) given its status as the only FDA-approved treatment for IgG4-RD.”

Investors are responding to the news, reflecting optimism about Amgen’s potential to capitalize on the new treatment’s market exclusivity and its impact on the company’s revenue streams.