Pfizer Studies Affected person Dying in Lengthy-Time period Trial of Hympavzi for Hemophilia A

A affected person taking Pfizer’s authorized hemophilia A remedy Hympavzi has died, the New York pharma disclosed Monday.

The affected person had been taking part in a long-term observe up medical trial that includes Hympavzi, which was authorized in October 2024 for sufferers with hemophilia A or B with out inhibitors. Pfizer revealed the demise in a letter to affected person communities.

The demise occurred on December 14. The affected person was initially enrolled in a Section III examine that occurred in 2022 and transitioned into an extension section in 2023. They continued to obtain Hympavzi as a prophylaxis plus recombinant issue VIIa to forestall bleeding after a minor surgical procedure. The affected person skilled critical opposed occasions together with a stroke and bleeding within the mind.

Pfizer mentioned it’s working with the info monitoring committee to assemble details about the demise. The corporate famous co-existing medical circumstances and different medicines the affected person was taking on the time.

Hympavzi was authorized within the U.S. in October 2024 as a once-weekly subcutaneous prophylactic injection for hemophilia A or B. It has since been granted authorization in Europe.

The remedy is an IgG1 monoclonal antibody that targets the Kunitz area 2 of the tissue issue pathway inhibitor protein, which prevents blood clotting. This mechanism of motion permits Hympavzi to boost coagulation in hemophilia sufferers.

Earlier this yr, Pfizer discontinued the hemophilia gene remedy Beqvez in all world markets, citing low affected person curiosity and a shift to Hympavzi. Pfizer partnered with Sangamo Therapeutics on Beqvez.

In September 2024, Pfizer pulled the sickle cell illness remedy Oxbryta from the market after new information confirmed the next danger of demise and problems in sufferers who acquired it.