Hemophilia drug trial halted after patient death: 3 things to know

Alnylam Pharmaceuticals stopped treating patients with its experimental drug fitusiran following the death of a clinical trial participant, according to Reuters.

Here are three things to know.

1. Fitusiran is intended to treat patients with hemophilia, a rare disorder which impedes the body's ability to properly clot blood.

2. The clinical trial patient died from a blood clot that burst in his brain. Clinicians originally misdiagnosed the patient as having a hemorrhage unrelated to the experimental drug. However, an independent review later cited the clot as the cause of death.

3. Alnylam plans to reevaluate the dosage and frequency of fitusiran in light of the patient death.

"Following further investigation of this safety finding, implementation of a risk mitigation strategy and alignment with global regulatory authorities, we expect to resume fitusiran dosing in our clinical studies as soon as possible, potentially as early as late 2017," said Akshay Vaishnaw, MD, PhD, executive vice president of research and development at Alnylam.

More articles on supply chain:

Novo Nordisk settles diabetes drug lawsuit for $58.7M: 3 things to know
Supply chain tip of the day: Consider seasonal indexes when demand planning
Patient death spurs FDA to halt cancer drug trials

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars