First oral GLP-1 treatment for T2DM is approved
The FDA approved semaglutide (Rybelsus) once-daily oral tablets to improve control of blood glucose in adult patients with type 2 diabetes mellitus (T2DM) along with diet and exercise. Semaglutide is the first FDA-approved glucagon-like peptide (GLP-1) receptor protein treatment that does not need to be injected. Semaglutide is a product of Novo Nordisk.
Semaglutide is not for use in patients with type 1 diabetes mellitus or those with diabetic ketoacidosis. It is not known if semaglutide is safe and effective for use in children under 18 years of age. The product slows digestion, prevents the liver from making excessive sugar, and aids the pancreas in insulin production when required.
As a standalone therapy, semaglutide resulted in a significant blood sugar reduction compared with placebo via hemoglobin A1C (A1C) tests. After 26 weeks, 69% of patients taking semaglutide 7 mg once daily and 77% taking 14 mg once daily decreased their A1C to lower than 7% (compared with 31% of patients taking placebo).
The product labeling for semaglutide includes a boxed warning to advise healthcare providers and patients about the potential increased risk of thyroid C-cell tumors and to notify that semaglutide is not recommended as the first choice of medications for treating diabetes. Consult the full prescribing information for more information.
FDA approves treatment for adults and children with all genotypes of hepatitis C
The FDA expanded the approval of glecaprevir/pibrentasvir (Mavyret) tablets for an 8-week duration for the treatment of adults and children age 12 and older or weighing at least 99 lb (44.9 kg) who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection, compensated cirrhosis, and are treatment-naive for HCV infection.
Glecaprevir/pibrentasvir is now the first 8-week treatment approved for all treatment-naive adults and certain pediatric patients with HCV genotypes 1 to 6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.
Glecaprevir/pibrentasvir is contraindicated in patients with moderate or severe liver impairment or in those with any history of liver decompensation; it is also contraindicated in patients taking atazanavir and rifampin.
Drug approved for the treatment of IBS with constipation
Tenapanor (Ibsrela) is now approved for the treatment of adults with inflammatory bowel syndrome with constipation (IBS-C). Tenapanor is a minimally absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C. Tenapanor is a twice-daily, 50-mg pill taken immediately before breakfast or the first meal of the day and immediately before dinner.
Tenapanor was evaluated in two randomized, double-blind, placebo-controlled trials and demonstrated a significant reduction in constipation and abdominal pain in both trials.
Tenapanor is contraindicated in patients less than 6 years of age and should be avoided in patients 6 years to less than 12 years of age. The safety and effectiveness of the drug have not been established in pediatric patients less than 18 years of age. Tenapanor is also contraindicated in patients with known or suspected mechanical GI obstruction.
Diarrhea was the most common adverse reaction in clinical trials of tenapanor. Severe diarrhea was reported in 2.5% of tenapanor-treated patients. Dosing should be suspended if severe diarrhea occurs, and the patient should be rehydrated.