Pharming NV submits rhC1INH to EMEA

Dutch biotechnology firm Pharming NV says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA), which requests approval for its recombinant human C1 inhibitor (rhC1INH) for use in acute hereditary angiodema. HAE, which is a genetic condition characterized by painful swelling of the soft tissues, can be fatal if left untreated.

The MAA is supported by data from clinical studies, in which the product brought about relief from the condition less than two hours after administration. The firm added that the product, which will be manufactured through its collaboration with the Akzo Nobel subsidiary Dyosynth BV if approved, has already received Orphan Drug designation for the HAE indication from the EMEA.