Pfizer Reports Patient Death Linked to Side Effects in Hempazzi Study

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New York: Pfizer has announced the death of a patient who was receiving treatment with its blood-thinning drug Hempazzi as part of a long-term clinical study, after the patient experienced serious side effects.

The European Haemophilia Consortium said the patient died on December 14 after suffering a stroke followed by a brain haemorrhage. The individual was enrolled in a study evaluating Hempazzi in patients with haemophilia A or B, with or without inhibitors.

In a statement, Pfizer said it is working closely with the trial investigator and an independent external data monitoring committee to gather further information and better understand the “complex and multi-factorial circumstances” surrounding the incident.

Hempazzi, which is administered as a once-weekly injection, received US regulatory approval last year for the prevention or reduction of bleeding episodes in patients aged 12 and older with haemophilia A or B. The treatment works by targeting blood clotting proteins.

Pfizer added that, based on its current assessment, it does not expect the incident to have an impact on the overall safety profile of the drug for patients currently being treated.