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Pharming Receives Fast Track Designation From US FDA For Recombinant Human C1 Inhibitor

01 Aug 2006 - Pharming Group NV announced that it has received a Fast Track designation on recombinant human C1 inhibitor (rhC1INH) for the treatment of hereditary angioedema (HAE) from the US Food and Drug Administration (FDA).
 
There is no approved therapy available to HAE patients in the US for the treatment of acute attacks. Clinical studies of rhC1INH have shown that treatment with Pharming's rhC1INH leads to rapid time to beginning of relief from the attack and reduces time to complete resolution. The rhC1INH product has already been granted Orphan Drug status in this indication which provides a seven year period of market exclusivity in the US upon product approval.
 
"The Fast Track designation from FDA will help Pharming achieve its goal of delivering rhC1INH to HAE patients as quickly as possible," said Dr. Francis Pinto, CEO of Pharming. "We look forward to working with FDA to provide a treatment option for HAE patients in the United States."