Pharming receives fast-track status for recombinant human C1 inhibitor

By E. Janene Geiss

Philadelphia, July 28 - Pharming Group NV announced Friday that it has received a fast-track designation from the Food and Drug Administration on recombinant human C1 inhibitor for the treatment of hereditary angioedema.

The fast-track designation provides an expedited review process for products used to treat serious or life-threatening diseases with limited treatment options and where the product has the potential to have a positive effect on the condition, according to a company news release.

The designation also allows for more frequent interactions with the FDA, which could improve the efficiency of product development and decrease the typical review period.

There is no approved therapy available to hereditary angioedema patients in the United States for the treatment of acute attacks.

Clinical studies have shown that treatment with recombinant human C1 inhibitor leads to rapid time to beginning of relief from the attack and reduces time to complete resolution.

The product has already been granted orphan-drug status in this indication, which provides a seven year period of market exclusivity in the United States upon product approval, officials said.

Hereditary angioedema is a human genetic disorder caused by a shortage of C1 inhibitor activity. The disease is characterized by acute attacks of painful swelling of soft tissues, including regions of the skin, the intestine and the mouth and throat.

Pharming, based in Leiden, The Netherlands, is a biotechnology company.

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