GSK scraps plan to launch oral anemia drug in EU, ceases further expansion efforts

Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter.

Daprodustat, marketed as Jesduvroq in the U.S., earned backing from the drug evaluation committee at the European Medicines Agency a month ago. The recommended indication was for treating anemia associated with chronic kidney disease (CKD) in patients on chronic dialysis. From there, an official approval from the European Commission was largely considered a done deal.

But in reporting its second-quarter financial results (PDF) on Wednesday, GSK said it has decided not to commercialize daprodustat in Europe. The company said it will withdraw the application in Europe and won’t seek approvals in other territories. Besides the U.S., daprodustat is also available in Japan under the brand name Duvroq. It's distributed there by Kyowa Kirin.

In making this decision, GSK cited the “significant reduction” in the size of the drug’s potential market opportunity, the fact that the EMA didn’t include non-dialysis patients in its opinion, and other existing rivals. Thanks to a 2021 go-ahead, FibroGen’s partner Astellas has been selling rival drug Evrenzo, or roxadustat, in Europe for CKD anemic patients regardless of their dialysis status. And in April, Akebia's vadadustat won an EU green light for dialysis-dependent patients.

Despite Evrenzo's broad label in Europe, Astellas recently booked an impairment charge worth 47.1 billion Japanese yen ($340 million) based on its reduced sales outlook for the drug. During the 12 months that ended in March, Evrenzo only brought in 3.2 billion yen ($23 million) for Astellas across Japan and EU. In China, where FibroGen is partnered with AstraZeneca, the drug generated $209 million in 2022.

In recent years, discrepancies among drug regulators in the U.S., EU and Japan have been laid bare in their reviews of the HIF-PHI drug class. Jesduvroq, Evrenzo and Vafseo all belong to this group, which once looked promising enough to replace injectable erythropoietin-stimulating agents.

Japanese authorities embraced all three drugs early on, endorsing them in dialysis-dependent and nondialysis CKD patients.

In the U.S., heart disease and other safety signals prompted the FDA to completely reject FibroGen and AstraZeneca's roxadustat in 2021. The agency knocked back vadadustat, too, based on similar cardio risk factors, but it now appears open to re-considering the med in the dialysis-dependent population after Akebia's appeal. As for GSK's Jesduvroq, the drug in February became the first oral treatment for CKD-related anemia approved in the U.S., but it’s not allowed for patients who aren’t on dialysis.

Before the safety fallout, analysts had predicted blockbuster sales for members of the HIF-PHI class. GSK had previously predicted around 500 million pounds to 1 billion pounds of peak sales for Jesduvroq. Now, the drug will obviously have a hard time reaching that mark.