Steglatro Approved to Treat Type 2 Diabetes
December 20, 2017 – The U.S. FDA has approved Steglatro™ (ertugliflozin), manufactured by Merck and Pfizer, to be used in conjunction with diet and exercise to improve glycemic control for adults who have type 2 diabetes.
Steglatro, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is the fourth drug in its class to receive FDA approval. It helps to control blood sugar levels by preventing the reabsorption of glucose by the kidneys, which increases the amount of glucose excreted in urine. Recommended dosing is 5mg once each morning, with or without food. If the patient tolerates treatment well and requires additional help controlling blood sugar, dosage can be increased to 15mg once per day. Steglatro will be available in both 5mg and 15mg tablets.
In addition to its approval of Steglatro, the FDA approved two ertugliflozin combination products: Segluromet™ (ertugliflozin and metformin) and Steglujan™ (ertugliflozin and sitagliptin). Other SGLT2 inhibitors currently available in the United States include AstraZeneca’s Farxiga® (dapagliflozin), Boehringer Ingelheim/Lilly’s Jardiance® (empagliflozin), and Janssen’s Invokana® (canagliflozin).
Launch is expected in early 2018. Although pricing plans have not yet been announced, Steglatro is expected to be priced comparably to other SGLT2 inhibitors (approximately $3,400 per year at wholesale).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.