AMGN's Uplizna Gets FDA Nod for 2nd Rare Autoimmune Disease Indication

Core Viewpoint - Amgen's drug Uplizna has received FDA approval for a new indication to treat immunoglobulin G4-related disease (IgG4-RD), marking it as the first and only FDA-approved treatment for this condition [1][2]. Group 1: Drug Approval and Market Impact - Uplizna is now approved for treating adults with IgG4-RD, a chronic disease with significant unmet medical needs [2]. - The approval is based on the phase III MITIGATE study, which demonstrated an 87% reduction in the risk of flares compared to placebo [3][4]. - Year to date, Amgen's shares have increased by 18.9%, outperforming the industry average rise of 1.2% [2]. Group 2: Clinical Study Insights - The MITIGATE study's primary endpoint was to assess the time to first flare in patients with IgG4-RD [3]. - In the study, 58.8% of Uplizna-treated participants achieved flare-free, corticosteroid-free, and complete remission at week 52, compared to 22.4% in the placebo group [4]. Group 3: Future Developments - Amgen is also exploring Uplizna for generalized myasthenia gravis (gMG) and plans to submit a regulatory filing for this indication by the first half of 2025 [5][6]. - Uplizna generated sales of $379 million in 2024, and further label expansions are expected to drive sales growth in future quarters [6].