Pharming seeks EMEA approval for Rhucin for attacks of hereditary angioedema

By Lisa Kerner

Charlotte, N.C., Aug. 17 - Pharming Group NV said its Marketing Authorization Application for recombinant human C1 inhibitor (rhC1INH or Rhucin) for treatment of acute attacks of hereditary angioedema (HAE) has been accepted for review by the European Medicines Agency (EMEA).

The company expects EMEA's initial response and questions about marketing approval for Rhucin later this year.

Pharming said in clinical studies, all HAE patients treated with Rhucin demonstrated a rapid time to beginning of relief - typically less than two hours - and time to minimal symptoms - typically less than 12 hours.

Rhucin, if approved, will represent the first new therapy for HAE patients in more than 30 years, according to a company news release.

HAE, a genetic disorder, is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema) lasting up to five days.

Pharming, located in Leiden, The Netherlands, develops protein products for the treatment of genetic disorders.

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