GSK abandons European launch of revolutionary anemia drug, daprodustat, despite positive evaluation

UNITED KINGDOM —In a surprising turn of events, GSK has decided to forego the European launch of its highly-anticipated oral anemia drug, daprodustat, marketed as Jesduvroq in the U.S.

Despite gaining a positive opinion from the European Medicines Agency’s drug evaluation committee just a month ago, the company has opted out of bringing this FDA-approved wonder drug to Europe or any other markets worldwide.

Jesduvroq belongs to a groundbreaking class of medications known as oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI), which had been hailed as the future of anemia treatment. However, safety concerns and label restrictions have somewhat hindered their widespread adoption.

When GSK reported its second-quarter financial results, it took the pharmaceutical world by surprise with its decision not to commercialize daprodustat in Europe.

The application will be withdrawn, and the company will not seek approvals in other territories beyond the U.S., where daprodustat is already available under the brand name Duvroq, and in Japan, where it is distributed by Kyowa Kirin.

One of the key reasons cited by GSK for this unexpected move is the “significant reduction” in the potential market opportunity for the drug.

Additionally, the fact that the European Medicines Agency’s opinion only covered dialysis patients and not non-dialysis patients further dampened GSK’s prospects.

Adding to the challenges were existing competitors like FibroGen’s Evrenzo (roxadustat), which received approval for treating CKD anemia in Europe, regardless of dialysis status, and Akebia’s vadadustat, which also won EU approval for dialysis-dependent patients.

It’s important to note that while Evrenzo received a broad label in Europe, Astellas, its partner, had to write off a staggering 47.1 billion Japanese yen (US$340 million) due to reduced sales expectations for the drug.

The HIF-PHI drug class, which includes Jesduvroq, Evrenzo, and Vafseo, has faced discrepancies in reviews among drug regulators in the U.S., EU, and Japan.

However, the Japanese authorities have been early adopters of all three drugs, endorsing them for both dialysis-dependent and nondialysis CKD patients.

In contrast, the U.S. FDA initially rejected FibroGen and AstraZeneca’s roxadustat in 2021 due to safety concerns related to heart disease.

Vadadustat also faced a similar setback but is now being re-considered for dialysis-dependent patients after Akebia’s appeal.

As for GSK’s Jesduvroq, it gained FDA approval in February as the first oral treatment for CKD-related anemia but was limited to use in dialysis patients only.

The decision comes as a shock to many, as analysts had previously predicted blockbuster sales for drugs in the HIF-PHI class.

GSK itself had anticipated peak sales of Jesduvroq to be in the range of 500 million pounds (US$645.8 million) to 1 billion pounds (US$1.3 billion).

However, with the current turn of events, achieving those sales figures seems increasingly challenging for the drug.

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