TRENDING TOPICS

FDA APPROVES DAPRODUSTAT (JESDUVROQ™)

The FDA has approved the first oral treatment for anemia caused by CKD for adults who have been receiving dialysis for ≥ 4 months. Daprodustat is a hypoxiainducible factor prolyl hydroxylase (HIF PH) inhibitor which increases erythropoietin levels, thereby signaling production of red blood cells (RBCs). It is approved as 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg tablets; it is dosed once daily based on pre-treatment hemoglobin (Hb) levels or erythropoiesis stimulating agent (ESA) dosage if switching therapies. Prior to initiation, other causes of anemia should be excluded or corrected; liver testing should also be performed. Iron status must be assessed in case supplemental iron is needed during treatment. Dosage increases should be no more frequently than every 4 weeks, and therapy should be discontinued if a clinically meaningful increase in Hb is not seen after 24 weeks. Daprodustat carries a boxed warning for increased risk of death, MI, stroke, venous thromboembolism, and thrombosis of vascular access. Daprodustat is not indicated as a substitute for RBC transfusion in patients who require immediate correction of anemia. Further, it should not be used in patients who are not on dialysis. The drug has not been shown to improve quality of life, fatigue, or patient well-being.

Approval was based on the randomized, open-label, phase 3 ASCEND-D trial (n=2,964) which included adults with CKD who were on dialysis for ≥ 90 days and who had an Hb level between 8 to 11.5 g/dL. Patients were assigned to receive either daprodustat or an injectable ESA (darbepoetin alfa or epoetin alfa). The co-primary non-inferiority outcomes were mean change in Hb from baseline to weeks 28 through 52, and first occurrence of a major adverse cardiovascular event (MACE; composite of death from any cause, nonfatal MI, and nonfatal stroke). Results showed a mean change in Hb level from baseline to weeks 28 through 52 of 0.28 g/dL in the daprodustat group and 0.1 g/dL in the ESA group (difference, 0.18 g/dL, 95% CI, 0.12 to 0.24), which met the pre-specified non-inferiority margin. After a median follow-up of 2.5 years, MACE occurred in 25.2% of patients taking daprodustat and 26.7% of patients in the ESA group (HR, 0.93; 95% CI, 0.81 to 1.07), which met the pre-specified non-inferiority margin.

BEHAVIORAL HEALTH CORNER: NSDUH REPORT

Results from the 2021 National Survey on Drug Use and Health (NSDUH) by SAMHSA have been released. Overall, 14.1 million US adults (5.5%) had serious mental illness (SMI), with young adults ages 18 to 25 years and multiracial adults having the highest rates of SMI. Serious thoughts of suicide were reported by 4.8% of adults. For adolescents ages 12 to 17 years, 20.1% had a major depressive episode and 12.7% had serious thoughts of suicide. Among 133.1 million alcohol users ≥ 12 years of age, 45.1% were binge drinkers. There were 9.2 million people aged ≥ 12 years who misused opioids (heroin or prescription pain relievers), and 46.3 million people (16.5%) who had a substance use disorder (SUD), including alcohol use disorder (29.5 million), drug use disorder (24 million), and both alcohol and drug use disorders (7.3 million). The highest percentages of SUD were seen in American Indian or Alaska Natives, and multiracial people. Additional details are provided on use of mental health services, substance use treatments, and perceived recovery.

COVID-19: NOTABLE DEVELOPMENTS

The Executive Office of the President of the US has announced that the COVID-19 public health emergency will be terminated on May 11, 2023. Vaccine reimbursement, COVID-19 treatments, OTC and pharmacist-provided testing, and controlled substances prescribing will be affected. The FDA has revised the EUA for molnupiravir (Lagevrio™) and nirmatrelvir/ritonavir (Paxlovid™) to remove the requirement for positive SARS-CoV-2 test results prior to prescribing these drugs. The CDC has issued an MMWR on early estimates of bivalent mRNA booster dose vaccine effectiveness in preventing symptomatic SARS-CoV-2 infection from Omicron XBB/ XBB.1.5 in immunocompetent US adults from December 2022 to January 2023. Results showed that a bivalent mRNA booster dose provided additional protection against symptomatic XBB/XBB.1.5 infection for at least the first 3 months after vaccination in persons who had previously received 2 to 4 monovalent vaccine doses. Please refer to the COVID-19 disclaimer at the end of the publication.