Neuromyelitis optica spectrum disorder (NMOSD) is neuroinflammatory disease characterized by optic neuritis and myelitis with presence of anti-aquaporin-4 (AQP4) antibodies. Satralizumab is an anti-IL-6 receptor (IL-6R) humanized antibody approved for preventing relapses in NMOSD (AQP4 IgG positive) in adults and children in Japan.
Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune demyelinating disorder of the optic nerves and the spinal cord that is linked to the presence of anti-aquaporin (AQP4) autoantibodies. Satralizumab, a humanized anti-IL-6 receptor (IL-6R) antibody, has been approved for the treatment of NMOSD but the effects of IL-6R inhibition in myelitis severity have not been fully explored.
While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated.
Aeterna Zentaris Inc. has offered an update on its development pipeline programs. Macimorelin acetate (AEZS-130), a ghrelin agonist approved and commercialized as a test for adult growth hormone deficiency, is in preclinical development for amyotrophic lateral sclerosis (ALS). The company has now successfully developed an alternative formulation suitable for use in ALS.
Lapix Therapeutics Inc. has announced the successful outcome of its pre-IND meeting request with the FDA to achieve alignment on the company's IND-enabling plan for LPX-TI641, being developed for neuro-autoimmune indications such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myelin oligodendrocyte glycoprotein antibody disease (MOGAD).
Iaso Biotherapeutics Inc. raised ¥500 million (US$75 million) in a series C1 round as looks for its first drug approval by China after its NDA was accepted for what is claimed to be the first B-cell maturation antigen-targeting CAR T-cell therapy in China.
Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
DUBLIN – The cash spigot is still turned on, as two more European firms disclosed series A rounds on Oct. 13. Chord Therapeutics SA took in €16 million (US$18.8 million) to repurpose cladribine for rare autoimmune disorders. Rappta Therapeutics Oy raised €9 million to take forward a novel concept in cancer, focused on developing small-molecule activators of protein phosphatase 2A (PP2A).
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd. has launched a subcutaneous injection of Enspryng (satralizumab) in Japan to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica (NMO).
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd. has launched a subcutaneous injection of Enspryng (satralizumab) in Japan to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica (NMO).
