Exemed Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug
New Delhi: The drug major Exemed Pharmaceutical has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination antidiabetic drug Linagliptin plus Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin (2.5mg+10mg/ 5mg+ 5mg/ 2.5mg+5mg) Tablets.
This came after the firm presented their proposal along with more evidence and supporting literature for the proposed FDC in lower strength (Linagliptin 5mg plus Dapagliflozin 5mg) based on their clinical trial report of higher strength (Linagliptin 5mg plus Dapagliflozin 10mg).
The firm informed that they have withdrawn two strengths i.e. Linagliptin + Dapagliflozin (2.5mg+10mg/ 2.5mg+5mg).
Linagliptin is a medicine used to treat type 2 diabetes. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly. This can cause high blood sugar levels (hyperglycemia). Linagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Dapagliflozin inhibits the sodium-glucose cotransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
