Uplizna, for NMOSD, Being Offered by BioCareSD and BioTek Remedys in US
Uplizna (inebilizumab-cdon), a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD), is now available in the U.S. through specialty distributor BioCareSD and specialty infusion pharmacy BioTek Remedys.
The companies added the medication to their portfolio of specialty therapeutics to expand upon their product offering and serve a wider population of patients, especially those who are underserved.
“We are continuously anticipating, identifying and supporting the unmet needs of our customers,” Andrew Kirk, chief operating officer at BioCareSD, said in a press release. “We are committed to broadening our portfolio of product offerings as new life-saving medications become available, further increasing access to critical therapeutics that serve more patient groups.”
Uplizna, marketed by Horizon Therapeutics, is approved in the U.S. to treat adults with NMOSD who test positive for aquaporin-4 water channel autoantibodies (AQP4-IgG). After an initial round of two start-up doses, given two weeks apart, the treatment is given as an into-the-vein infusion twice a year.
It works by lowering the levels of B-cells — a type of immune cell responsible for antibody production — in the body, thereby reducing autoantibody production in people with NMOSD.
Its approval was based on positive data from the N-MOmentum Phase 2/3 clinical trial (NCT02200770), which evaluated the safety and effectiveness of Uplizna against a placebo in 230 adults with NMOSD.
Participants were randomly selected to receive either 300 mg of Uplizna (174 patients) or a placebo (56 patients) via infusion on days 1 and 15, after which they were followed for about six months.
The trial met its primary goal of reducing relapse rates. Among patients with AQP4-IgG antibodies, 89% of those receiving Uplizna remained relapse-free over the trial’s duration, compared with 58% of those on a placebo.
Uplizna also reduced pain and significantly lowered the proportion of participants who experienced a worsening disability — measured as rising Expanded Disability Status Scale (EDSS) scores over the six months (15.5% vs. 33.9%).
After completing the trial, all patients could opt to be part of an open-label extension study and receive 300 mg of Uplizna every six months. An analysis of patients treated with Uplizna for four or more years in N-MOmentum and the open-label extension demonstrated that 83% remained attack-free since starting on the treatment.
“The clinical evidence surrounding UPLIZNA in the treatment of NMOSD patients has been overwhelmingly positive,” Carla Sparkler, chief marketing officer at BioTek Remedys, said in another press release.