Takeda announces acceptance of European Marketing Authorisation application for Peginesatide

Takeda Pharmaceutical Company Limited (Takeda) today announced that Takeda Global Research & Development Centre (Europe) Ltd received confirmation of acceptance for assessment from the European Medicines Agency (EMA) for a Marketing Authorisation Application (MAA) for the investigational compound peginesatide for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Takeda had submitted the MAA earlier this month.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA) which results in the increased formation of red blood cells. The agent was discovered by Affymax, and if approved, will be co-marketed by Affymax and Takeda in the United States, and by Takeda in the European Union.

The MAA submission for peginesatide was supported mainly by data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed three times per week (according to the product labels), in maintaining hemoglobin (Hb) levels. The EMERALD studies were part of the largest Phase 3 clinical program to support the initial registration of an ESA. The program enrolled more than 2,600 patients, including approximately 1,600 dialysis patients. In the studies, CKD patients on dialysis who were receiving stable doses of epoetin, were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was similar to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia. In addition the two groups had a similar safety profile.

In May 2011, Takeda’s U.S. partner, Affymax, submitted a New Drug Application for peginesatide to the U.S. Food and Drug Administration (FDA). The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to CKD in December 2011, and a Prescription Drug User Fee Act (PDUFA) date of March 27, 2012, is scheduled for peginesatide.

“This MAA represents a significant milestone for our company and carries positive clinical implications for patients with anemia in chronic kidney disease and the physicians who treat them,” said Stuart Dollow, M.D., managing director, Takeda Global Research & Development Centre (Europe) Ltd. “Although anemia is a debilitating condition for chronic kidney disease patients on dialysis, appropriate management of this condition is onerous for patients and healthcare professionals. Our program illustrates the potential of peginesatide as an important once-monthly therapeutic option. We are committed to bringing new treatments to patients with unmet needs, and look forward to working with the EMA as they review the data package for the peginesatide MAA.”

References

1. National Kidney and Urologic Diseases Information Clearinghouse. “Anemia in Kidney Disease and Dialysis”
2. Astor et al Association of Kidney Function with Anemia: The Third National Health and Nutrition Examination Survey (1988-1992). Archives of Internal Medicine 2002; 162: 1401-1408
3. National Heart Lung and Blood Institute “What is Anemia.” http://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_what_is.html.
4. Fishbane et al. “Hemoglobin Cycling in Hemodialysis Patients Treated With Recombinant Human Erythropoietin.” Kidney International 2005; Vol. 68 (2005), pp. 1337-1343