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
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
