enrollment has been completed in the 2nd of 4 Phase 3 clinical trials, as of 11/08; NDA expected to be filed in 2010; independent Data Monitoring Committee completed its final scheduled review and supports continuation of the studies (11/09); top-line phase 3 results expected 2Q2010; 4 phase III trials met primary endpoints and demonstrated non-inferiority to Epogen and Aranesp; however concerns over cardiac events in the pre-dialysis subgroup, including higher rates of death, unstable angina, and arrhythmia (6/10); NDA expected to be submitted 1H2011, pending meeting with FDA (8/10)
Brand Hematide Generic N/A
Company name Affymax, Takeda Product type Speciality
Therapeutic category Hematologic agents Key uses anemia in chronic renal failure patients
Other Uses N/A Drug Class synthetic peptide-based erythropoiesis stimulating agent (ESA)
Dosage From SC, IV injection Expected Approval 2011-Q4
FDA Filing N/A Last Update date August 09,2010
Link to news release
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Link to clinicaltrials.gov
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