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news.Pharming Group's clinical trial application for an investigational angioedema treatment has received approval from Health Canada, meaning the company can expand clinical development in Canada.
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Pharming will now conduct clinical trials to assess the safety and efficacy of its recombinant human C1 inhibitor (rhC1INH) to treat acute attacks of hereditary angioedema (HAE), a genetic disorder characterized by attacks of swelling of soft tissues.
The protocol involves a randomized, double blind, placebo controlled trial for rhC1INH in HAE patients and will be conducted at multiple centers across Canada.
Pharming is currently conducting a randomized, double blind, placebo controlled phase III clinical trial for rhC1INH across Europe. Under an investigational new drug application (IND) granted by the FDA, the company has also expanded clinical studies with rhC1INH to the US.
In clinical studies, HAE patients treated with rhC1INH showed a significant decrease in time to beginning of relief and time to complete resolution with no adverse effects reported to date.
Pharming expects to file for approval of rhC1INH with the European Agency for the Evaluation of Medical Products (EMEA) later this year.