AMAG Pharmaceuticals (AMAG)

[mlkrborn]

AMAG $15

"1:07AM AMAG Pharma reports positive data from the FIRST Trial, a head-to-head comparison trial of Ferumoxytol compared to iron sucrose (AMAG) 15.55 : Co announces positive new data from the FIRST head-to-head trial comparing Feraheme(R) (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease. Overall, this randomized controlled clinical trial demonstrated that ferumoxytol 1.02 g, delivered as two injections of 510 mg within 5 3 days, had a favorable safety profile and comparable efficacy to 1 g of iron sucrose dosed as 100 mg or 200 mg over 5 to 10 injections given over 2 to 2.5 weeks. Safety and efficacy data in the poster include: Patients treated with ferumoxytol had lower overall rates of adverse events (48% vs. 65%), related adverse events (10% vs. 16%), and adverse events leading to drug discontinuation (1% vs. 5%) compared to patients treated with iron sucrose. Serious adverse events, related SAEs, and AEs of special interest were similar between the two treatment groups. Ferumoxytol-treated patients had a comparable increase in hemoglobin at Week 5 from baseline compared with patients treated with iron sucrose, however, higher Hgb values were observed at all time points following treatment through Week 5 in ferumoxytol-treated patients compared to patients treated with iron sucrose. More ferumoxytol-treated patients (50%) achieved a >=1 g/dL increase in Hgb compared with patients treated with iron sucrose (42%). Ferumoxytol-treated patients had a faster time to response (28.5 days vs. 32.9 days) than did patients treated with iron sucrose. "