Updated NMOSD Diagnostic Criteria, Tavapadon NDA Submitted, MIL-62 Shows Promising Treatment Effects in NMOSD

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

At the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 24-26, in Barcelona, Spain, the International Panel for Neuromyelitis Optica Diagnosis (IPND) presented new evidence-based diagnostic criteria and updated nomenclature for neuromyelitis optica spectrum disorder (NMOSD). The latest framework distinguished aquaporin-4 antibody–positive (AQP4-IgG+) NMOSD as a distinct disease and reclassified related seronegative conditions as separate syndromes. The panel, a steering committee of 26 members and 60 special advisors as well as consensus faculty, conducted a comprehensive review of data published since the last published consensus guidelines in 2015.2 Using a systematic literature approach and a modified Delphi consensus process, experts revised criteria for diagnosing AQP4-IgG+ NMOSD and clarified guidance on testing and interpretation of aquaporin-4 antibodies.

AbbVie has submitted a new drug application (NDA) to the FDA for tavapadon, its investigational selective dopamine D1/D5 receptor partial agonist, for the treatment of Parkinson disease (PD).¹ The application is supported by data from the phase 3 TEMPO program, which demonstrated symptomatic improvements across multiple clinical trials.^2,3 Three randomized, placebo-controlled phase 3 trials—TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193), which evaluated tavapadon in early-stage PD; and TEMPO-3 (NCT04542499), which assessed its use as adjunctive therapy to levodopa in patients with motor fluctuations—provided supporting data. Additionally, an interim analysis from TEMPO-4 (NCT04760769), which is an ongoing, open-label extension trial, also contributed to the application.

Findings from a phase 3, randomized, double-blind, placebo-controlled trial (NCT05314010) showed that treatment with MIL62 (Mabworks Biotech), a glycoengineered type II anti-CD20 monoclonal antibody, led to low relapse risk and reduced disability progression in aquaporin-4 (AQP4)-IgG-positive neuromyelitis optica spectrum disorder (NMOSD). Over a 52-week treatment period, 4.4% of patients (2 of 25) randomized to MIL62 experienced a relapse compared with 45.7% (21 of 46) of those on placebo (HR, 0.069; 95% CI, 0.016-0.296; P <.001). In addition, investigators recorded an annualized relapse rate (ARR) of 0.092 in the MIL62 group vs 1.180 in the placebo cohort.

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