CHMP negative on Rhucin for HAE
Netherlands-based biotechnology company Pharming Group NV says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion regarding the approval of Rhucin for hereditary angioedema.
Pharming said that, according to currently-available information, the CHMP had not been reassured that the drug had a beneficial effect on laryngeal sub-mucosal attacks. The firm also said that the CHMP was thought to be concerned about the safety and efficacy of repeat Rhucin treatments in HAE patients
Pharming added that it disagreed with the CHMP's findings and intends to apply for a re-examination of Rhucin before the end of the year.
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