FDA investigating risk of hypocalcemia in patients on dialysis taking Prolia
The FDA is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease who are on dialysis and are treated with the osteoporosis medication Prolia (denosumab). Results from an ongoing safety study of Prolia suggest an increased risk of hypocalcemia in patients with advanced kidney disease; a second study investigating hypocalcemia in patients on dialysis treated with Prolia shows a substantial risk with serious outcomes, including hospitalization and death.
The agency is alerting healthcare professionals about these risks because of their frequency and seriousness. The agency is continuing to investigate the issue and advises healthcare professionals to consider the risks of hypocalcemia with the use of Prolia in patients on dialysis: "When Prolia is used in these patients, adequate calcium and vitamin D supplementation and frequent blood calcium monitoring...may help decrease the likelihood or severity of these risks."
Prolia is a product of Amgen.
Second interchangeable biosimilar insulin to Lantus approved
Rezvoglar (insulin glargine-aglr) was approved by the FDA as the second interchangeable biosimilar insulin product to Lantus (insulin glargine). Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Rezvoglar is available in a 3 mL single-patient-use KwikPen prefilled pen.
Rezvoglar may cause serious adverse reactions, including hypoglycemia, severe allergic reactions, hypokalemia, and heart failure, according to labeling. Rezvoglar is a product of Eli Lilly.
Pediatric indication approved for chronic hepatitis B treatment
The FDA approved an expanded indication for Gilead Sciences' Vemlidy (tenofovir alafenamide) 25 mg tablets for the once-daily treatment of chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease.
The agency previously approved Vemlidy as a once-daily treatment for adults with chronic HBV with compensated liver disease. Approval of the pediatric indication was based on data from a clinical trial comparing treatment with Vemlidy 25 mg to placebo among treatment-naive and treatment-experienced patients ages 12 to less than 18 years weighing at least 35 kg (77.2 lb). The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy. Overall, 21% of those treated with Vemlidy 25 mg achieved HBV DNA levels less than 20 IU/mL at 24 weeks compared with 0% of subjects treated with placebo.
Vemlidy contains a boxed warning about posttreatment severe acute exacerbation of hepatitis B.
First drug approved that can delay onset of T1DM
The FDA approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes mellitus (T1DM) in adult and pediatric patients 8 years and older who currently have stage 2 T1DM. This first-in-class therapy has the potential to delay clinical diagnosis of T1DM by approximately 2 years. The drug is administered via I.V. infusion once daily for 14 consecutive days.
Tzield is a CD3-directed antibody that may deactivate the immune cells that attack insulin-producing beta cells while increasing the proportion of cells that help moderate the immune response, according to the FDA and the drug's manufacturer, Provention Bio.
The most common adverse reactions that occurred during treatment and through 28 days after the last study drug administration were lymphopenia, rash, leukopenia, and headache.