New GSK closer to first U.S. approval with anemia drug for patients on dialysis

[October 27, 2022]  By Leroy Leo and Khushi Mandowara

(Reuters) -GSK Plc came closer to securing its first drug approval since its consumer health spin-off in July as an expert panel of the U.S. health regulator backed an approval for its drug to treat anemia in some patients with chronic kidney disease (CKD).

The advisers to the Food and Drug Administration on Wednesday voted 13-3 in favor of the oral drug for patients on dialysis, although GSK was expecting approval for a broader CKD population.

"The statistical data (was)... more reassuring for this population than for the ND (not on dialysis) population," said panelist Thomas Wang from UT Southwestern Medical Center in Texas.

The panel, hesitant about backing the drug for patients not on dialysis, voted 11-5 against it for that group, citing increased safety risks such as heart failure.

A possible approval would be a key win for GSK as it seeks to convince investors that the lack of a consumer health distraction will boost its track record of scientific execution.

GSK's drug, daprodustat, is the first from the HIF-PH inhibitor class to win U.S. FDA panel's endorsement. Similar drugs from FibroGen and AstraZeneca, and Akebia Therapeutics have failed to secure approvals.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/

HIF-PH inhibitors are a class of oral drugs designed to boost production of red blood cells by mimicking the body's response at high altitudes, where a lack of oxygen leads to increase in red cell numbers and hemoglobin concentration.

The FDA, which usually follows the recommendations of its expert panel, is expected to make its final decision on the drug by Feb. 1.

So far, daprodustat tablets have only been approved by Japan in June 2020, and is sold under brand Duvroq.

According to the Centers for Disease Prevention and Control, about 37 million adults in the United States are estimated to suffer from CKD.

(Reporting by Khushi Mandowara and Leroy Leo in Bengaluru; additional reporting by Natalie Grover in London; Editing by Shinjini Ganguli)

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