GSK Wins Approval for CKD Anemia Drug – with Conditions

GSK_Leon Neal/Getty Images

Courtesy of Leon Neal/Getty Images

Wednesday, the FDA approved GSK’s daprodustat, now marketed as Jesduvroq, for treating anemia due to chronic kidney disease (CKD) in adult patients. 

According to GSK, Jesduvroq is the “first innovative medicine for anemia treatment in over 30 years” and is the only FDA-approved hypoxia-inducible factor prolyl hydroxylase inhibitor.

Regulators slapped Jesduvroq with a boxed warning, however, calling attention to a heightened risk of death, stroke, myocardial infarction, venous thromboembolism and thrombosis of vascular access associated with the use of the drug. The drug also increases the risk of major adverse cardiovascular and thrombotic vascular events.

There is currently no known dose or dosing strategy for Jesduvroq that does not increase these risks.

Jesduvroq’s use is also limited to patients receiving dialysis for at least four months.

The FDA’s approval closely follows the recommendations of its Cardiovascular and Renal Drugs Advisory Committee (RDAC), which in October 2022 leaned toward approving the drug in dialysis-dependent patients.

Citing the excess risk of side effects, the independent experts at the time deemed Jesduvroq’s risk-benefit profile unfavorable for patients who did not require dialysis treatment.

However, since healthcare providers could reasonably manage toxicities, given appropriate label warnings, the committee felt the drug’s efficacy was compelling enough to outweigh potential risks in dialysis patients.

Data from the Phase III ASCEND clinical program were the focus of the RDAC meeting – and ultimately supported Jesduvroq’s approval. The program includes five Phase III trials, each assessing the efficacy and safety of the drug across the disease spectrum. Overall, more than 8,000 patients were enrolled and treatment lasted more than four years.

One Down, Three to Go

In its full-year financial report, GSK named four FDA anticipated approvals for 2023. One of these was for Jesduvroq.

The company now awaits a regulatory verdict on momelotinib, an investigational oral drug that inhibits JAK1 and JAK2 signaling, as well as the activin A receptor type I protein, to treat myelofibrosis.

In January 2022, Sierra Oncology reported that momelotinib met its primary endpoint of total symptom score reduction of over 50% in the Phase III MOMENTUM trial. GSK acquired Sierra in April for $1.9 billion.

The FDA is also set to decide on GSK’s respiratory syncytial virus vaccine for older adults. In October 2022, the candidate aced a pivotal Phase III trial, showing an overall vaccine efficacy rate of 82.6%. The shot proved even more effective in older adults and those with underlying comorbidities.

Finally, additional approvals for Jemperli (dostarlimab) are expected in endometrial cancer.

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