“Supported by a strong biological rationale, we expect to initiate two pivotal Phase III studies of aplisna in autoimmune hepatitis and chronic inflammatory demyelinating by the second half of this year.”

In context

“nnual Meeting. Olpasiran, our potentially best-in-class small interfering RNA medicine that delivers greater than 95% reduction in Lp(a) with a quarterly dosing schedule, continues to progress in Phase III clinical investigation for secondary prevention of cardiovascular events. We have recently initiated the OCEANA CCTA study that evaluates the effect of olpasiran on the burden of non-calcified plaque in coronary arteries, as measured by coronary CT angiography. Attention to Lp(a) in medical practice is rising, reflected by the recently updated ACC/AHA lipid guidelines that now recommend broader Lp(a) testing. Moving to rare disease, we continue to build strong momentum across our portfolio. For APLISNA, we recently received European Commission approval for generalized myasthenia gravis. Supported by a strong biological rationale, we expect to initiate two pivotal Phase III studies of aplisna in autoimmune hepatitis and chronic inflammatory demyelinating by the second half of this year. We are also advancing TEPEZZA, where we recently reported positive Phase III top-line data for subcutaneous administration via an on-body injector. These data demonstrated robust efficacy in patients with thyroid eye disease consistent with intravenous administration alongside a favorable safety profile. Subcutaneous administration of TEPEZZA represents an important step forward in improving convenience, and expanding treatment options for patients with thyroid eye disease. Dazodalibet, our first-in-class CD40 ligand-targeting fusion protein, continues to progress with two Phase III studies in Sjogren’s disease now fully enrolled. These studies address both systemic and symptomatic disease, and both are expected to complete later this year. As publicly disclosed, the FDA proposed to withd”