Monday October 1, 7:15 am ET Application for Acute Treatment of Hereditary Angioedema Granted Priority Review
NEW YORK--(BUSINESS WIRE)--Lev Pharmaceuticals, Inc. ("Lev" or the "Company") (OTCBB:LEVP.OB - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of its Biologics License Application (BLA) for Cinryze(TM) (C1 inhibitor) for the acute treatment of hereditary angioedema (HAE). In addition, the FDA has designated the submission for priority review, which targets an FDA action by January 30, 2008. Lev submitted the BLA on July 31, 2007. Priority review status is granted by the FDA to products that, if approved, would be a significant improvement over existing therapies.
"We are extremely pleased that the FDA has accepted our Cinryze(TM) BLA for filing and designated it for priority review," said Joshua D. Schein, Ph.D., Chief Executive Officer of Lev. "The priority designation supports our belief in the potential of Cinryze(TM) as a replacement therapy for the treatment of HAE. There currently is no acute therapy specifically approved for the treatment of HAE, and we believe that Cinryze(TM), if approved, would represent an important option in improving the lives of patients with the disease."
The BLA submission is based on data from the Company's pivotal Phase III acute trial which met its protocol-defined, pre-specified primary endpoint with statistical significance as reported on March 14, 2007. Additional details regarding the acute study results will be presented at the 2007 Annual Meeting of the American College of Allergy, Asthma & Immunology in November.
Priority Review Designation Targets FDA Action by January 30, 2008 for Both Acute and Prophylactic Indications
NEW YORK--(BUSINESS WIRE)--Lev Pharmaceuticals, Inc. (“Lev” or the “Company”) (OTCBB: LEVP ) today announced the submission of an amendment to its pending Biologics License Application (BLA) for Cinryze™ (C1 inhibitor) for the treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency. The amendment includes the data from the Company’s pivotal U.S. Phase III trial of Cinryze™ for the prophylactic treatment of HAE.
As previously announced on October 1, 2007, the FDA accepted for filing the Company’s BLA for Cinryze™ for the acute treatment of HAE and designated the submission for priority review, targeting an FDA action by January 30, 2008. This submission of the prophylactic data will allow the FDA to complete a comprehensive review for both the acute and prophylactic indications of Cinryze™ without affecting the priority review timeline. Priority review status is granted by the FDA to products that, if approved, would be a significant improvement over existing therapies.
“Today’s announcement marks the achievement of another important milestone for Lev,” said Joshua D. Schein, Ph.D., Lev’s Chief Executive Officer. “The submission of the prophylactic data reconfirms our previously stated guidance and potentially moves us one step closer to providing a comprehensive treatment option for HAE patients in 2008," added Schein.
On September 10, 2007, Lev reported positive results from its pivotal U.S. Phase III trial of Cinryze™ for the prophylactic treatment of HAE. In the study, the protocol-defined, pre-specified primary endpoint was achieved, showing a clinically and statistically significant reduction in the number of HAE attacks.
On March, 14 2007, Lev announced the successful completion of its pivotal Phase III clinical trial for the acute treatment of HAE, which demonstrated a clinically and statistically significant reduction in the time to unequivocal relief of acute HAE attacks.
Lev is the only company developing both acute and prophylactic indications for the comprehensive treatment of HAE in the United States.
About Lev Pharmaceuticals, Inc.
Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. Lev’s C1 inhibitor, proposed to be marketed as CinryzeTM, has been granted orphan drug status for the treatment and prevention of HAE, potentially securing, upon approval, market exclusivity for seven years. Lev has also received fast track designation status from the FDA, which facilitates the development and expedites the review of drugs and biologics intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. Lev is also evaluating the development of C1 inhibitor for the treatment of acute myocardial infarction, or heart attack, and selective other diseases and disorders in which inflammation is known or believed to play an underlying role. <<
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