Pharming's Angioedema Drug Found to Be Effective in Open Label Studies
Posted on: Friday, 11 July 2008, 09:00 CDT
Pharming Group has announced positive results from ongoing open-label studies with recombinant human C1 inhibitor for the treatment of acute attacks of hereditary angioedema.
The positive results are from the treatment of 123 acute hereditary angioedema (HAE) attacks in 64 patients with different doses of Rhucin in the ongoing European and North American open-label studies. Rhucin has been consistently safe and effective in patients receiving up to nine treatments with no evidence of decreased response to the study drug.
Importantly, all seven serious laryngeal attacks treated in these studies responded rapidly to Rhucin. The open-label data are consistent with findings from Pharming's two randomized, double-blind, placebo-controlled studies of Rhucin with a median time to onset of relief of one hour and a median time to minimal symptoms of four hours.
The results from open-label studies confirm Rhucin to be safe and effective in the repeat treatment of acute HAE attacks at different dosage regimens. No clinically relevant adverse reactions were reported from these studies. The open-label treatments represent a substantial increase to the Rhucin clinical database and will be used to support planned regulatory submissions.
Source: Datamonitor
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