美国Affymax
Omontys(peginesatide,一种聚乙二醇化的合成肽)治疗有慢性肾脏病(CKD)透析成人患者的贫血。
At Affymax, we discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses. Our first marketed product, OMONTYS® (peginesatide) Injection was approved by the U.S. Food and Drug Administration (FDA) in March 2012 for the treatment of anemia associated with chronic kidney disease in adult patients on dialysis. We plan to establish the company as a supportive partner to the physicians and dialysis providers caring for these patients.
Milestone Timeline
2001 – Incorporated in July in Delaware
2003 – Lead compound, OMONTYS, selected for clinical development
2004 – OMONTYS entered the clinic
2006 – Worldwide collaboration for OMONTYS established with Takeda Pharmaceutical Company Limited
2006 – IPO in December, Nasdaq symbol AFFY
2007 – Initiated Phase 3 trials for OMONTYS
2008 – Enrollment completed in Phase 3 trials for OMONTYS
2010 – Completed treatment and follow-up in Phase 3 OMONTYS trials
2010 – Data from Phase 3 trials for OMONTYS announced
2011 – OMONTYS NDA accepted for review by the FDA
2012 – OMONTYS approved by the FDA