Mexico’s COFEPRIS waves through Pfizer’s SGLT2 inhibitor trio



Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has publicized recent market approvals for Pfizer’s anti-diabetics Steglatrocv (ertugliflozin), Steglatrocv-Dpp (ertugliflozin + sitagliptin), and Steglatrocv-Duo (ertugliflozin + metformin), as GBI analysis reveals. The tablets are indicated as an adjunct to diet and exercise to treat type 2 diabetes (T2D) in adult patients.

Small-molecule inhibitor (SMI) ertugliflozin acts on the glucose-reabsorbing sodium-glucose co-transporter 2 (SGLT2) to reduce the uptake of filtered glucose back into the body and increase urinary glucose excretion, while dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin prevents the inactivation of incretin hormones that regulate glucose homeostasis, and metformin decreases hepatic glucose production, inhibits intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

GBI analysis shows that Steglatrocv-Dpp is not approved in other Latin American markets, while development partner Merck, Sharp & Dohme (MSD) has registered Steglatrocv and Steglatrocv-Duo in Argentina under the brand names Steglatro and Segluromet respectively, according to GBI SOURCE. Pfizer’s products will compete in Mexico with other SGLT2 inhibitor-based products such as Janssen’s Invokana (canagliflozin) and Invokana Duo (canagliflozin + metformin), Boehringer Ingelheim’s Jardianz (empagliflozin), Jardianz Duo (empagliflozin + metformin), and Jardianz Dpp (empagliflozin + linagliptin), and AstraZeneca’s Forxiga (dapagliflozin) and Qtern (dapagliflozin + saxagliptin).

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