European Union watchdog puts sickle cell disease drug on ice

European Union suspends Pfizer's Oxbryta for sickle cell disease due to safety concerns, urging doctors to stop use immediately.

The European Union's drug watchdog on Thursday, September 26, 2024, called for the suspension of approval for Pfizer's medicine to treat sickle cell disease, saying doctors should stop using the drug.

The European Medicines Agency's call came a day after the U.S. pharmaceutical giant said it was "voluntarily withdrawing" Oxbryta from global markets.

Oxbryta is used to treat sickle cell disease (SCD), the potentially fatal blood disorder that primarily affects millions of people of African, Middle Eastern or South Asian descent.

"The EMA's human medicines committee (CHMP) has recommended suspending marketing authorisation for ... Oxbryta," the Amsterdam-based agency said. "This measure is taken as a precaution while a review of emerging data is ongoing," it added in a statement.

Two studies said patients who used Oxbryta showed a higher occurrence of so-called "vaso-occlusive crises" -- acute pain and potential complications such as arthritis, kidney failure and stroke.

The EMA was already reviewing the risks of Oxbryta in a probe that started in July.

"This was triggered as data from a clinical trial showed that a higher number of deaths occurred with Oxbryta than with placebo treatment," the EMA said. "Another trial showed the total number of deaths was higher than anticipated," it added.