Carbidopa Levodopa Fractional Tablet Launched, Tenecteplase Shows Benefit After 24-Hour Window, Biogen Issues Response to CMS on Aducanumab

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This week Neurology News Network covered the launch of the first carbidopa levodopa fractional tablet, a phase 2a study that found new benefits with tenecteplase past the 24-hour window, and a response letter from Biogen to the CMS regarding its approved Alzheimer treatment aducanumab.

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

The first carbidopa/levodopa (CD/LD) fractional tablet (Dhivy; Avion Pharmaceuticals) designed to be divided, has been commercially launched for the treatment of Parkinson disease (PD), the company recently announced. The announcement follows FDA approval of the formulation in November 2021, which facilitates more precise medication dosing in patients with PD.The smallest precise dose of CD/LD available, 6.25/25 mg, is contained in each tablet’s 4 segments, totaling 25/100 mg per tablet. As patients treated with CD/LD report difficulty managing individual off-time and adverse effects related to precise dosing of medication, the fractional tablet is designed with deep scores and in order to allow patients to divide it and precisely match their recommended dose of medication. If too much CD/LD is taken, patients can develop complications such as dyskinesia. Additionally, imprecise dosing can trigger off-episodes that result in temporary paralysis.

Findings from a phase 2a study showed that administration of tenecteplase between 4.5 to 24 hours from time of last known well is effective in achieving major reperfusion without symptomatic intracranial hemorrhage in patients with ischemic stroke. These data, presented at the 2022 International Stroke Conference (ISC), February 7-9, in New Orleans, Louisiana, indicate that tenecteplase seems feasible to extend the time window of IV thrombolysis to 24 hours after last known well through perfusion imaging selection. Based on these finding, investigators will move forward with examining the effects of the lower dose, 0.25 mg/kg, in a future phase 2b study. The primary outcome, major reperfusion without symptomatic intracranial hemorrhage (sICH), was achieved in 14 of 43 patients (32.6%) in the lower dose tenecteplase group and in 10 of 43 patients (23.3%) in the higher dose group. Three months posttreatment, 53.5% of the patients were no more than slightly disabled, indicating that while not able to carry out all previous activities, they did not require daily assistance. Furthermore, 38.4% of participants either had no significant symptoms of residual neurological deficits or had mild symptoms but were able to return to pre-stroke activities of daily living.

Biogen, the developer of aducanumab (Aduhelm) 100-mg/mL injection, a monoclonal antibody (mAb) for the intravenous treatment of Alzheimer disease (AD), has issued a statement in response to the proposed national coverage determination (NCD) from the Centers for Medicare & Medicaid Services (CMS), which states that the government’s health insurance program would only cover the administration of the medication for patients who are partaking in CMS-approved randomized control trials that satisfy its criteria, as well as those in trials supported by the National Institutes of Health. The proposed insurance program was published by CMS in a decision memo in January 2022, with Biogen responding with a 31-page comment in February, asserting that patients with AD should have immediate access to treatments that have been FDA-approved. Additionally, the company stated that questions raised by CMS pertaining to this class of treatments may be more appropriately addressed through data from “real-world use.”

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