Pharming Group N.V.
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Publicatie datum
28 jul 2006 - 08:00
Statutaire naam
Pharming Group N.V.
Titel
PHARMING RECEIVES FAST TRACK DESIGNATION FROM US FDA FOR RECOMBINANT HUMAN C1 INHIBITOR
Bericht
Leiden, The Netherlands, July 28, 2006. Biotech company Pharming Group NV (“Pharming”) (Euronext: PHARM) (PHARM.AS) announced today 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).
The Fast Track designation provides an expedited review process for products used for treatment of serious or life-threatening diseases with limited treatment options and where the product has the potential to have a positive effect on (the symptoms of) the condition. 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 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.”
Background on Hereditary Angioedema
Hereditary angioedema is a human genetic disorder caused by a shortage of C1 inhibitor activity. Approximately one in 30,000 individuals suffers from HAE and has an average of seven acute attacks per year. HAE attacks that are untreated usually last up to five days. The disease is characterized by acute attacks of painful swelling of soft tissues (edema), including regions of the skin, the intestine, and the mouth and throat. If the soft tissue of the throat i
Datum laatste update: 21 december 2025