AstraZeneca Share Price Dropped 0.93% on the FDA Drug Approval

The AstraZeneca (LON: AZN) share price dropped 0.93% after it was revealed that Ultomiris has received approval in the United States for its groundbreaking role as the first and only extended-duration C5 complement inhibitor tailored for adults diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are positive for the anti-aquaporin-4 (AQP4) antibody.

This innovative treatment promises a potentially relapse-free existence for those affected by AQP4 antibody-positive (Ab+) NMOSD, marking a significant advancement in managing this rare neurological condition.

The US Food and Drug Administration (FDA)'s decision to approve Ultomiris was influenced by compelling evidence from the CHAMPION-NMOSD Phase III clinical trial. The findings from this trial, which highlighted Ultomiris' efficacy compared to a placebo group from the pivotal Soliris PREVENT study, were published in the Annals of Neurology.

Ultomiris achieved its primary trial goal by demonstrating a significant extension until a patient's first relapse, as validated by an independent review committee. In the study, patients treated with Ultomiris exhibited no relapses over a median duration of 73 weeks, achieving a relapse risk reduction of 98.6% (hazard ratio (95% CI): 0.014 (0.000, 0.103), p<0.0001).

NMOSD is an uncommon, chronic autoimmune condition that aggressively attacks the central nervous system, including the spinal cord and optic nerves, leading to severe and often recurrent relapses. 

These episodes can bring about new neurological symptoms or exacerbate existing ones, potentially causing lasting impairment. The estimated prevalence of NMOSD among adults in the US is around 6,000 individuals, underscoring the need for effective treatments like Ultomiris.

Sean J. Pittock, MD, Director of Mayo Clinic's Center for Multiple Sclerosis and Autoimmune Neurology and of Mayo's Neuroimmunology Laboratory and lead primary investigator in the CHAMPION-NMOSD trial, said: “C5 inhibition has been proven to offer efficacy in reducing the risk of NMOSD relapses by blocking the complement system, a part of the immune system, from attacking healthy cells in the spinal cord, optic nerve and brain. With today's FDA approval, patients now have the option of a long-acting C5 inhibitor treatment that showed zero relapses in the pivotal CHAMPION-NMOSD trial, supporting the primary goal of relapse prevention in treating NMOSD.”

AstraZeneca share price. 

The AstraZeneca share price dropped 0.93% to trade at 10382.0p from Friday’s closing price of 10479.0p.