Dec 23 (Reuters) - A patient who was being treated with
Pfizer's ( PFE ) hemophilia drug, Hympavzi, as part of a
long-term study died after experiencing serious side effects,
the company said.
The individual died on December 14 after suffering a stroke
followed by a brain hemorrhage, according to the European
Haemophilia Consortium, a patient support group.
The patient was enrolled in a study that was testing
Hympavzi in patients with hemophilia A or B with or without
inhibitors.
"Pfizer ( PFE ), together with the trial investigator and the
independent external Data Monitoring Committee, are actively
gathering information to better understand the complex,
multi-factorial circumstances surrounding this occurrence," the
company said in a statement.
The therapy, a once-a-week injection, gained U.S. approval
last year to prevent or reduce bleeding episodes in hemophilia A
or B patients aged 12 years and older by targeting
blood-clotting proteins.
Pfizer ( PFE ) does not anticipate any impact to safety for patients
treated with the drug based on its current knowledge and the
overall clinical data collected to date, the company said.
People with hemophilia have a defect in a gene that
regulates the production of proteins called clotting factors,
causing spontaneous and severe bleeding following injuries or
surgery.
Earlier this year, Pfizer ( PFE ) said it would halt global
development and commercialization of its hemophilia gene
therapy, Beqvez, citing soft demand from patients and their
doctors.
Beqvez, a one-time therapy, was approved in the U.S. for the
treatment of adults with moderate to severe hemophilia B.