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GSK's Daprodustat Drug for Anemia Due to CKD Gets FDA Nod

GSK PLCGSK announced that the FDA approved its daprodustat drug, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis. Daprodustat is to be marketed under the brand name Jusduvroq in the United States and claims that it is the first innovative drug for anemia treatment in over 30 years.

In the past year, the shares of GSK have plunged 36.8% compared with the industry’s fall of 8%.

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The FDA approval was based on the results of the ASCEND-D phase II study which evaluated the efficacy and safety of Jesduvroq (daprodustat) for the treatment of adult patients with anemia of CKD on dialysis. The study showed that the mean change in the hemoglobin level from baseline to weeks 28 through 52 was 0.28±0.02 g per deciliter in the group of patients who underwent the administration of daprodustat compared to 0.10±0.02 g per deciliter in those administered with erythropoiesis-stimulating agents (ESA). This result met the predetermined primary endpoint of the study of achieving a noninferiority margin of −0.75 g per deciliter.

The secondary safety endpoint of a predetermined noninferiority margin of the study was also met with only 25.2% of patients treated with daprodustat, compared with 26.7% of patients treated with ESA, suffering a major adverse cardiovascular event.

Daprodustat is approved as Duvroq in Japan for the treatment of patients with anemia of CKD, while a regulatory application is also under review in Europe with a regulatory decision anticipated in the first half of 2023.

The FDA accepted GSK’s new drug application (NDA) for daprodustat in April 2022. The NDA was based on data from the ASCEND phase III program, which consisted of five studies. All the studies met their primary efficacy and safety endpoints in non-dialysis and dialysis CKD patients.

We remind investors that in October last year, the FDA’s Cardiovascular and Renal Drugs Advisory Committee gave a mixed opinion on the NDA seeking approval of daprodustat for anemia of CKD. The panel voted 13-3 in favor of daprodustat’s treatment benefits outweighing the risks in adult dialysis patients with anemia of CKD. However, for adult non-dialysis patients with anemia of CKD, the committee voted 5-11 against the benefits outweighing the risks.

CKD causes progressive loss of kidney function with anemia as a common complication. Anemia of CKD further increases morbidity and mortality while severely affecting the quality of life. Approximately 39 million people in the United States are affected by CKD out of which 6 million are also affected by anemia.

Jesduvroq (daprodustat), a HIF-PHI, has the potential to correct anemia by the transcription of erythropoietin and other genes, brought about by the inhibition of oxygen-sensing prolyl hydroxylase enzymes, that stabilizes hypoxia-inducible factors.

However, GSK’s daprodustat will be facing stiff competition from other players in the medical market like AstraZeneca PLC AZN, FibroGen FGEN and Akebia Therapeutics, Inc. AKBA.

AstraZeneca and partners, FibroGen and Astellas Pharma, received a complete response later (CRL) in August 2021 from the FDA for its anemia with CKD candidate, roxadustat. Per the FDA, NDA could not be approved and requested additional clinical studies to be conducted on roxadustat before resubmission.

AstraZeneca, FibroGen and Astellas’ Roxadustat is approved in the European Union under the brand name Evrenzo for the treatment of adult patients with anemia associated with CKD. The companies are yet to decide on a course of action for roxdustat’s application resubmission in the United States.

Additionally, Akebia’s anemia of CKD treatment candidate, vadadustat, received a CRL from the FDA back in March 2022. The rejection of the NDA was due to the absence of data regarding enough benefit against the risk of treatment with vadadustat for dialysis and non-dialysis patients. Akebia disputed the CRL and met with the FDA last November to discuss its formal dispute resolution request and received a request for submission of additional clarification. Akebia expects the submission to be made in the first quarter of 2023.

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GSK currently carries a Zacks Rank #3 (Hold).

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