Currently without a USFDA-approved acute therapy in the United States, Hereditary Angioedema (HAE) or hereditary C1-inhibitor deficiency is a rare and life-threatening inflammatory condition characterized by recurrent attacks of inflammation affecting the extremities (the hands and feet), the face, the urogenital tract, the abdomen, and the larynx.
This genetic disorder is caused by a deficiency of the plasma protein C1-INH.
While there is no current approved therapy for HAE in the U.S., C1-INH is the treatment of choice for HAE in Europe for more than 30 years.
Lev Pharmaceuticals, Inc. (OTC: LEVP) – maker of the C1-esterase inhibitor (C1-INH) – believes that replacement therapy with C1-INH will benefit the estimated 10,000 people with HAE in the United States.
Now, Lev Pharmaceuticals, Inc. is happy to announce that its pivotal U.S. Phase III trial of C1-esterase inhibitor (C1-INH) for the acute treatment of hereditary angioedema (HAE) has reached the protocol-defined primary endpoint - demonstrating a clinically and statistically significant reduction in the time to sustained relief of acute HAE symptoms.
According to Michael Frank, M.D., Distinguished Professor, Departments of Pediatrics and Medicine, Duke University School of Medicine, and an Investigator in the Phase III trial:
"The results of this study confirm the extensive clinical experience in Europe where C1-inhibitor has been used to treat acute HAE attacks for more than 30 years. Upon FDA approval, this therapy will be welcomed by all patients with this debilitating disease.”
Following such positive clinical data, Lev will submit a Biologics License Application (BLA) to the Food and Drug Administration in the second quarter of 2007.
Read the full press release.
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