Pharming to resubmit Rhucin MAA

Dutch biotechnology company Pharming has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP), after re-examination of its initial opinion, will adopt a negative view on the Marketing Authorization Application for Rhucin (recombinant human C1 inhibitor) to treat acute attacks of hereditary angioedema. Based on this development, the company intends to refile its marketing application for Rhucin with additional data and request expedited European Union regulatory review.

Pharming understands that the CHMP does not have a specific concern on the safety and efficacy data submitted in the MAA and has accepted all the non-clinical and quality aspects of the product. However, it is not reassured that there is sufficient evidence to confirm the clinical benefits of Rhucin in repeat use. In particular, the Committee is not convinced about the potential for undesirable immune responses following repeated administration. The re-examination procedure by the EMEA included a review by an independent scientific advisory group composed of experts in the field of HAE. According to the firm, there was consensus by the CHMP's members, recognizing that the available clinical data were limited and that there was no evidence to indicate the development of neutralizing antibodies to C1-inhibitor with repeat administration of Rhucin.