The U.S. Meals and Drug Administration has accepted Sanofi-Aventis’s Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric sufferers with diabetes mellitus.
Merilog is a rapid-acting human insulin analog and the primary rapid-acting insulin biosimilar product accepted by the FDA. Administering Merilog subcutaneously 5 to 10 minutes earlier than mealtime helps enhance glycemic management in sufferers with diabetes. Each a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial are included on this approval.
Severe negative effects reported with Merilog embrace hypoglycemia, extreme allergic reactions, and low potassium ranges within the blood. Frequent negative effects embrace injection website reactions, itching, rash, pores and skin thickening or pitting on the injection website, weight achieve, and swelling of palms and ft.
“The FDA has now approved three biosimilar insulin products to treat diabetes,” Peter Stein, M.D., director of the Workplace of New Medicine within the FDA Middle for Drug Analysis and Analysis, mentioned in an company press launch.
“Today’s approval highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin. Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.”
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FDA approves first rapid-acting insulin biosimilar for sufferers with diabetes (2025, February 20)
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