24-Hour Levodopa Solution Improves ON Time, Eisai Submits sBLA for Traditional Approval of Lecanemab, Rare Case of Seronegative NMOSD Identified


Neurology News Network for the week ending January 14, 2022. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

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

Newly announced data from the phase 3 randomized, double-dummy BouNDless trial assessing NeuroDerm’s 24-hour/day subcutaneous infusion of liquid levodopa/carbidopa (LD/CD), met its primary end point of improvement in ON time among patients with Parkinson disease (PD).The drug, ND0612, is designed to improve the pharmacokinectic profiles of oral LD/CD by avoiding gastric involvement and maintaining stable and continuous therapeutic levodopa plasma concentrations. Over a 12-week treatment period, patients randomly assigned to the agent demonstrated a statistically superior difference of 1.72 hours in good ON time (<.0001). Regulatory submissions for ND0612 in the US are expected to come this year and later in the European Union. ND0612 also demonstrated clinically meaningful results on the key secondary end point of OFF time (<.0001), as well as other end points include the Movement Disorder Society (MDS)-Unified Parkinson’s Disease Rating Scale Part II score (<.0001), the Patient Global Impression of Change (PGIC), and the Clinical Global Impression of Improvement.

On the same day the FDA approved Eisai’s antiamyloid therapy lecanemab (Leqembi) for patients with early Alzheimer disease (AD), the company announced it had submitted a supplemental biologics license application (sBLA) supporting the conversion of the accelerated approval of the agent to a traditional approval. The sBLA for the therapy is based on data from the phase 3 confirmatory Clarity AD trial.Accelerated approval is used to allow earlier approval of therapies that treat serious conditions and fill and unmet medical need based on a surrogate end point. Drug companies are still required to conduct phase 4 studies to confirmed the anticipated clinical benefit of the therapy. Designed as a humanized immoglobulin gamma 1 (IgG1) monoclonal antibody, lecanemab was approved under this pathway based on a phase 2 study known as Study 201, which demonstrated the drug’s significant effect on reducing amyloid-ß in the brain.

In a recent case report, a 35-year-old man from Nepal was diagnosed with seronegative neuromyelitis optica spectrum disorder (NMOSD) with longitudinally extending transverse myelitis (LETM) and Optic Neuritis based on 2015 diagnostic criteria. This was the first report of a diagnosis on seronegative NMOSD in Nepal although there have been few reported cases of LETM attributed to NMOSD with anti-aquaporin 4-immunoglobulin G (AQP4-IgG)-positive status. The patient reported weakness below both knee joints and had difficulty walking, which was associated with bowel and bladder incontinence, with a progression of being unable to walk later. The weakness of bilateral lower limb along with bowel and bladder incontinence occurred for 2 days. The patient entered the emergency department with no comorbidities present and no significant findings were observed upon general examination. Motor examination showed power of 0/5 below the bilateral knee joints with upgoing plantars. Reflex and tone examination showed an exaggerated response at bilateral lower limb as both patellar and ankle clonus were present.

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