FDA Panel Hearing on Roxadustat Leads the Week


FDA staff raised safety concerns ahead of the advisory panel hearing.

Thumbs down for roxadustat. On Thursday, the FDA Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval for roxadustat for anemia in patients with chronic kidney disease (CKD). Panelists cited safety issues in two votes against approval: 12-2 in patients who are on dialysis and 13-1 in patients who not on dialysis. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is being developed to treat anemia in patients with CKD. HIF-PHI drugs aim to restore production of the hormone erythropoietin and improve iron regulation; currently, the condition is treated by injections of epoetin alpha and darbepoetin alpha. Enrique Conterno, chief executive officer of FibroGen, the drug’s sponsor, pledged to continue to work with the FDA. FibroGen is developing the drug with AstraZeneca.

More missed PDUFA dates in JAK inhibitors. Early Friday, manufacturers of two JAK inhibitors announced that FDA decisions on their supplemental New Drug Applications (sNDAs) would not be made by deadlines under the Prescription Drug User Fee Act (PDUFA). In both cases, companies are awaiting decisions on JAK inhibitors that would treat atopic dermatitis. AbbVie awaits word on Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis; last month, the company announced a delay in the FDA review of requested indications in active psoriatic arthritis and for adults with ankylosing spondylitis. Eli Lilly and Company and Incyte await a decision on Olumiant (baricitinib) for the treatment of adults with moderate to severe atopic dermatitis (AD). Both drugs have been approved for other indications. The review is related to FDA’s ongoing review of JAK inhibitors, after a post-marketing study of Pfizer’s JAK inhibitor Xeljanz in patients with rheumatoid arthritis triggered a Drug Safety Communication warning of higher risks of cancer and a higher occurrence of serious heart-related events.

Bayer approval in CKD with type 2 diabetes. Kerendia (finerenone) has received FDA approval as a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) for CKD in patients with type 2 diabetes. The drug is approved to cut the risk of eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes, also known as diabetic kidney disease. Approval is based on the FIDELIO-DKD study.

Treatment for chronic Graft vs Host Disease. Rezurock will be available in late August, following FDA approval this week after a previous delay. Rezurock (belumodusil) is the first small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes. Approval comes after a trial of 65 patients who had two to five prior lines of systemic therapy for cGVHD; those taking the study therapy had an overall response rate of 75% through cycle 7 day 1 of treatment, with 6% of patients achieving a complete response and 69% achieving a partial response. Sixty-two percent (62%) of responders did not require new systemic therapy for at least 12 months following response.

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