Tag Archive for: patient death

A letter published Wednesday in the NEJM links a stroke patient’s death to lecanemab. Eisai investigators respond.

One day ahead of a data presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference, Science reported a second patient death has been linked to Eisai and Biogen’s lecanemab.

A patient taking part in an FDA-sanctioned clinical trial assessing a CRISPR-based therapy for a rare form of Duchenne muscular dystrophy (DMD) has died. Few details related to the circumstances of the patient’s death are known at this time, including whether or not he had been dosed with the one-time gene therapy.

Shares of Foghorn Therapeutics were falling rapidly in premarket trading Tuesday after the company announced the FDA placed a full clinical hold on a Phase I dose escalation study. The trial had already been subject to a partial hold following a patient death.

The two fatal cases of acute liver failure took place in Russia and Kazakhstan after 5 to 6 weeks of Zolgensma infusion and about 1-10 days following the initiation of corticosteroid taper, according to the company.