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MSD gets approval to expand Januvia label
  • By Constance Williams
  • Published 2017.08.01 17:37
  • Updated 2017.08.01 17:37
  • comments 0

MSD Korea said Tuesday that its Januvia (ingredient name: Citigliptin), Janumet (Sitagliptin+ Metformin) and Janumet XR (Surf Complex) had won approvals to be prescribed for patients with mild and moderate kidney problems.

Januvia was the first DPP-4 inhibitor approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Korean Ministry of Food and Drug Safety식품의약품안전처 for the first time in 2008. It is currently the only DPP-4 inhibitor in the country and has a broad range of indications ranging from insulin to combination therapy.

The drug has secured a leading position in the DPP-4 inhibitor-based diabetes treatment market, where nine products are competing for the expansion of its indication for kidney function.

​​​​​​Patients with stage-3 severe renal impairment greater than 45 mL/min / 1.73 m2 and less than 60 mL/min / 1.73 m2 by glomerular filtration rate (eGFR) may be administered with appropriate doses on condition that they show no symptoms that may increase the risk of lactic acidosis

And the 25-mg Januvia can be administered to patients with severe renal impairment (creatinine clearance: CrCl <30 mL/min), including those with type 2 diabetes, and end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis.

However, regulators advised patients with renal impairment should receive treatment with caution. In particular, they pointed out the need for dose control when administered to renal patients.

According to IMS Health data, the annual outpatient prescription amount of DPP-4 inhibitor totals 365 billion won ($326 million), accounting for 62.7 percent of the total outpatient prescriptions for oral hypoglycemic of 582 billion won.

Also, the combined sales of the two products of Janumet and Janumet XR accounted for 39.4 percent of total sales of DPP-4 inhibitor and Metformin combination products, by amounting to about 83 billion won (Janumet: 55 billion won and Janumet XR: 28 billion won).

"The changed indications allow patients with mild and moderate renal impairment to receive prescriptions,” said Park Do-hee박도히, general manager of marketing in MSD Korea한국MSD. "With the launch of Januvia 25mg at the beginning of this year and the expansion of Janumet and Janumet XR indicates that more patients and medical professionals will be able to effectively manage type-2 diabetes with a renal disease by taking the Januvia family.”


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