FDA

Four months after patient death, FDA’s hold lifted on Alnylam’s fitusiran

The FDA has lifted its clinical hold on Alnylam’s blood clotting drug fitusiran following a four-month standstill.

The company’s Phase II and Phase III studies on the drug fitusiran came to a halt back in September when a patient died from a blood clot in the brain. Fitusiran is being tested against a rare bleeding disorder called hemophilia.

The clinical trial hold came just 10 months after Sanofi agreed to pay $100 million to opt in on the Phase III fitusiran study after partnering with Alnylam in a $700 million buy-in back in 2014. Although the patient death occurred as part of the Phase II trial, the partners put a pause on its Phase III study as well.

Now, Alnylam said the FDA approved amended protocols relating to the trials, and it expects to resume dosing patients by the end of this year. In November, Alnylam agreed with the FDA on new risk mitigation measures, including patient education regarding doses of replacement.

“We are pleased with the FDA’s decision to lift the clinical hold, as fitusiran holds the potential to help improve the lives of people living with hemophilia,” said Akin Akinc, VP and general manager of fitusiran at Alnylam. “With the additional risk mitigation measures in place, we look forward to the continued late-stage development of fitusiran and expect to resume dosing around year-end.”


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