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Horizon Therapeutics' treatment for rare NMOSD receives European Commission approval

DTMT Network

Ireland based Horizon Therapeutics has announced on May 2, 2022, that the European Commission (EC) has granted approval to its inebilizumab, marketed under brand name Uplizna as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+) after a positive opinion by Committee for Medicinal Products for Human Use of the European Medicines Agency on November 11, 2021.

NMOSD is a combined term used for neuromyelitis optica (NMO) and related syndromes, a rare, severe, relapsing, neuroinflammatory autoimmune disease attacking the optic nerve, spinal cord, brain and brain stem.

“NMOSD is a devastating disease with unpredictable attacks, cumulative and often irreversible damage and potential loss of vision and motor function, causing profound uncertainty for patients,” Vikram Karnani, executive vice president at Horizon said.

“Today’s approval of Uplizna marks a significant milestone for patients in Europe and for Horizon, bringing a new, targeted treatment option to people living with NMOSD,” he added.

Over 90% of the NMOSD patients experience repeat attacks within five years of an initial attack, which can result in significant, irreversible damage, with each subsequent attack building upon the damage caused by the previous, Horizon said in an official statement released on May 5, 2022.

“We have made great strides in understanding the pathogenesis of NMOSD and in identifying new, effective therapies for its treatment, such as Uplizna, which can be transformative for patients in Europe who live with the devastating effects of this disease,” Professor Friedemann Paul of the NeuroCure Clinical Research Center at Charité-Universitätsmedizin Berlin, said.

“Just a single attack can cause life-altering impact, pain and debilitation, including potential vision loss. It is paramount we’re able to diagnose and treat this disease early to prevent cumulative damage and permanent disability for patients,” he added.

Horizon said that the EC approval came after results from N-MOmemtum, the largest pivotal trial ever conducted in NMOSD showed 87.6% of AQP4-IgG+ NMOSD patients on the medication remained attack free for 28 weeks, with the vast majority remaining attack free for at least four or more years.


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