Date: 2012-03-02
Type of information:
Product name: peginesatide
Compound: peginesatide
Therapeutic area:
Action mechanism: 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.
Company: Takeda Pharmaceutical (Japan)
Disease: symptomatic anemia associated with chronic kidney disease (CKD) in adult patients on dialysis
Latest news: * On February 27, 2012, Takeda Pharmaceutical Company Limited 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 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 in February. 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.
Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. The product, upon approval, will be commercialized outside the United States by Takeda.
Patents:
Submission of marketing authorization application USA : 2012-05-00 (NDA submitted by Affymax)
Submission of marketing authorization application UE: 2012-02-00
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
