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News Breaks | | | | December 10, 2012 | | 11:22 EDT |  | AMAG | AMAG says ferumoxytol met both primary endpoints in two trials
AMAG said in trial IDA-301 the primary efficacy endpoint for U.S. regulators is the proportion of subjects who achieved a ¡Ý 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union regulators is the mean change in hemoglobin from baseline to week 5. In the IDA-301 trial, ferumoxytol achieved both primary efficacy endpoints. In IDA-302 the same primary efficacy endpoints were used and in the IDA-302 trial, ferumoxytol achieved both primary efficacy endpoints. In IDA-301, the overall rate of reported adverse events was higher in the ferumoxytol group than in the placebo group, although no new safety signals, outside of those described in the current Feraheme label, were observed in this study. In the IDA-302 trial, the overall rates of adverse events and related adverse events were comparable in ferumoxytol- and iron sucrose-treated subjects, and included many attributable to comorbid disease. However, the overall rate of SAEs, both related and unrelated as assessed by the investigator, was higher in ferumoxytol-treated subjects. | |
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News For AMAG From The Last 14 Days Check below for free stories on AMAG the last two weeks. |
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| June 11, 2013 | | 07:42 EDT |  | AMAG | Boston Biotech Conferences to host a conference
 Subscribe for More Information | | | June 10, 2013 | | 08:02 EDT | | AMAG | AMAG Pharmaceuticals obtains U.S. commercial rights to MuGard
Subscribe for More Information | | | June 7, 2013 | | 08:47 EDT | | AMAG | AMAG Pharmaceuticals submits type II variation for Rienso
AMAG Pharmaceuticals announced that its European commercial partner, Takeda Pharmaceutical Company, has submitted a type-II variation to the European Medicines Agency, or EMA, for Rienso. The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia, or IDA, in adult patients with chronic kidney disease to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. The EMA submission is comprised of data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom either did not achieve satisfactory results from or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the phase III studies, IDA-301 and IDA-302. Patients enrolled in IDA-301 were also eligible to participate in IDA-303, an extension study to evaluate repeat dosing with ferumoxytol. The data from these studies have previously been reported. | |
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