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Home Diseases conditions and syndromes EU watchdog puts sickle cell disease drug on ice

EU watchdog puts sickle cell disease drug on ice

by Medical Xpress
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Credit: National Institutes of Health

The EU’s drug watchdog Thursday 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 US pharmaceutical giant said it was “voluntarily withdrawing” Oxbryta from global markets.

Oxbryta is used to treat (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 authorization 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”— 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 ,” the EMA said.

“Another trial showed the total number of deaths was higher than anticipated,” it added.

The EMA recommended no new treatment with Oxbryta should be started.

Doctors should also tell patients to stop treatment with Oxbryta “and monitor patients for adverse events after treatment is stopped,” the EMA said.

Cycle cell disease is a group of inherited that produce abnormal hemoglobin, a protein that carries oxygen.

Healthy blood cells move through to carry oxygen to all parts of the body, the US-based Centers for Disease Control said.

In someone who has SCD, the hemoglobin is abnormal which causes the red blood cells to become hard and sticky and look like a C-shaped farm tool called a sickle, clogging .

“This can cause pain and other serious complications such as infection, acute chest syndrome and stroke,” the CDC said.

Pfizer said Wednesday it was “voluntarily withdrawing Oxbryta in all markets where it has been approved.”

“Pfizer’s decision is based on the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population,” the US-based pharmaceutical said.

© 2024 AFP

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EU watchdog puts sickle cell disease drug on ice (2024, September 26)
retrieved 26 September 2024
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