Phase 3b Trial of Aducanumab, Autoinjector FDA Approved for Fremanezumab, Ticagrelor Phase 3 Trial Announced

This week Neurology News Network covered the phase 3b trial of aducanumab, the FDA approval for the autoinjector of fremanezumab, and the announcement of the phase 3 THALES trial of ticagrelor for the treatment of stroke.

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

A new phase 3b clinical trial of aducanumab has been registered on ClinicalTrials.gov, with the FDA giving Biogen the green light to proceed with the re-dosing study as the company seeks to demonstrate the drug’s long-term safety and tolerability in patients with Alzheimer disease. The phase 3b, open-label study has an estimated enrollment of 2400 participants and an estimated start date of March 31, 2020. The study will aim to evaluate the long-term safety and tolerability of the anti-amyloid drug in patients who previously participated in aducanumab clinical trials, including those who had received the study drug as well as those who received placebo. It remains to be seen whether the FDA will grant the drug regular or priority review, which could substantially impact the drug’s potential approval timeline.

The FDA has approved an autoinjector for the delivery of fremanezumab an anti-calcitonin gene-related peptide approved for the prevention of migraine in adults. In September 2018, the FDA approved fremanezumab for the prevention of migraine in adults. The drug was originally made available for administration via a prefilled syringe indicated for one-time use. The drug’s previous FDA approval was based off data from 2 studies in the phase 3 HALO clinical trial program. In those trials, investigators observed that fremanezumab reduced monthly migraines by >50% in roughly 45% of patients with episodic migraine and in about 40% of patients with chronic migraine. Teva did not announce a specific date of availability for the autoinjector, but indicated that it will be available in the coming months.

AstraZeneca announced that phase 3 THALES trial of ticagrelor in the treatment of stroke met its primary end point, reducing the risk of the composite of stroke and death after an acute ischemic stroke or transient ischemic attack. The drug previously received FDA approval for lowering the risk of heart attack, or death from heart attack or stroke in patients with acute coronary syndrome in September 2018. At the time, the drug was approved in 60 mg and 90 mg doses. In the PEGASUS-TIMI 54 trial, ticagrelor reduced the risk of cardiovascular death in patients by 29%.

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