FDA advisers voted in favor of approving Ardelyx’s tenapanor for patients with chronic kidney disease on dialysis; US home births increased by about 12% between 2020 and 2021; surges in respiratory viruses, especially respiratory syncytial virus (RSV) among younger children are putting pediatric hospitals at capacity.
FDA Advisers in Favor of Tenapanor for Patients With CKD on Dialysis
More than a year after initially rejecting the drug, a panel of FDA advisers recommended the approval of Ardelyx’s tenapanor for patients with chronic kidney disease (CKD) on dialysis, Reuters reported. The advisory panel voted 9-4 in favor of tenapanor to be administered as a single therapy to manage high phosphate levels in the blood of patients with CKD on dialysis and 10-2 in favor of its use alongside existing treatment, with 1 member abstaining. Phosphate binders are currently the only FDA-approved treatment for hyperphosphatemia, a condition resulting in abnormally high phosphorus levels in the blood, which is a sign of kidney damage. The FDA is expected to make a final decision within 30 days.
Home Births Increased in US During COVID-19 Pandemic
A recent CDC National Vital Statistics Reports release shows US home births slightly increased in 2021 when COVID-19 rates were high and vaccines were not widely available, reaching the highest level seen in decades, The Associated Press reported. Of nearly 4 million births in 2021, almost 52,000 occurred at home. This reflects an approximate 12% increase from 2020 and follows a 22% increase between 2019 and 2020. The increases were seen across races and ethnicities, but were much less common among Hispanic women. Although reasons for this increase are unknown, potential factors include lack of access to vaccines, avoiding hospital settings, lack of insurance, and travel barriers.
Surge in Hospitalizations for Pediatric Respiratory Illnesses
Pediatric health provider groups are calling for the Biden administration to declare a national emergency for pediatric respiratory illnesses to help combat a surge in hospitalizations, The Hill reported. Hospitalizations for seasonal flu, respiratory syncytial virus (RSV), and other respiratory viruses among younger children are especially high this year, resulting in pediatric hospitals being at capacity with limited beds and staff. This further results in more children being cared for in community and adult hospitals, which may have limited to no capacity to care for them because they are still reeling from the strain of COVID-19 surges.