Brief: JR-131, long-acting erythropoiesis-stimulating agent, demonstrates equivalence in phase III study
17/01/2018 06:28
Jan 17 (Reuters) - Kissei Pharmaceutical Co Ltd 4547.T
* Says it and JCR Pharmaceuticals Co Ltd 4552.T jointly
announced positive results of the phase III study for JR-131, a
proposed biosimilar to darbepoetin alfa, a long-acting
erythropoiesis-stimulating agent for the treatment of renal
anemia
* In the Phase III study initiated in August 2016, JR-131
demonstrated equivalence in efficacy and safety compared with
darbepoetin
* Accordingly, in a primary endpoint of efficacy, the
equivalence
was verified for variations in hemoglobin concentration and the
similarity with regard to the safety profile was confirmed
Source text in Japanese:https://goo.gl/eXovsF
Further company coverage: 4547.T 4552.T
(Beijing Headline News)
((Beijing.HeadlineNews@thomsonreuters.com; +8601082555111;
Reuters Messaging: Pingping.Li1@thomsonreuters.com@reuters.net))