AstraZeneca gets CDSCO Panel Nod To update Prescribing Information of Antidiabetic FDC
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to AstraZeneca to update the prescribing information for the fixed-dose combination (FDC) antidiabetic drug Saxagliptin plus Dapagliflozin film-coated tablet with the modification under special warning and precautions for use as “If a patient presents with severe joint pain after starting the drug, continuation of drug therapy should be individually assessed.”
This came after the drug major AstraZeneca presented the proposal for an update in prescribing information for said FDC, changes based on the updated company core data sheet (CCDS) version 4 dated 23.11.2022.
Saxagliptin (Onglyza) is an oral antihyperglycemic drug in the dipeptidyl peptidase-4 (DPP-4) inhibitor class.
Saxagliptin is used with proper diet and exercise to treat high blood sugar (glucose) levels in patients with type 2 diabetes. Saxagliptin helps to control blood sugar levels by making the pancreas gland release more insulin. It also signals the liver to stop producing sugar when too much sugar is in the blood.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.
By inhibiting SGLT2, dapagliflozin blocks the reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity.
At the recent SEC meeting for Endocrinology and Metabolism held on 13th and 14th February 2023, the expert panel reviewed the proposal to update the prescribing information for the fixed-dose combination (FDC) antidiabetic drug Saxagliptin plus Dapagliflozin film-coated tablet presented by AstraZeneca.
After detailed deliberation, the committee recommended a grant of approval for the proposed update of the prescribing information with the modification under special warning and precautions for use as “If a patient presents with severe joint pain after starting the drug, continuation of drug therapy should be individually assessed.”
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