Lev says FDA grants C1-INH fast-track status for treatment of hereditary angioedema

By E. Janene Geiss

Philadelphia, Dec. 19 - Lev Pharmaceuticals, Inc. said Monday that its lead investigational product, C1-esterase inhibitor (C1-INH) has been granted "fast track" status by the Food and Drug Administration for the treatment of hereditary angioedema.

"In granting fast track status, the FDA has acknowledged that C1-INH has the potential to be an important therapy for the serious disease of hereditary angioedema," Joshua Schein, chief executive officer of Lev, said in a company news release.

"This is the only clinical trial underway, to our knowledge, for the development of a prophylactic treatment for this debilitating and life-threatening condition," Schein added.

Fast track programs are designed to facilitate development and expedited review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Compounds designated with fast track status are eligible for accelerated FDA review and/or early submission of portions of the associated Biologics License Application for marketing approval.

Lev said it initiated its phase 3 trial of C1-INH in the first quarter of this year.

The first part of the study, which is ongoing, is designed to examine the efficacy and safety of C1-INH in the treatment of acute attacks in hereditary angioedema.

The second part of the phase 3 study is specifically examining the ability of C1-INH to prevent such inflammatory attacks, officials said.

In Europe, C1-INH therapeutics are used as replacement therapy for the treatment of hereditary angioedema and are the treatment of choice for hereditary angioedema attacks, officials said.

Lev's objective is to bring C1-esterase inhibitor to the United States as both an acute and prophylactic treatment for hereditary angioedema.

In 2004, the company received orphan drug designation from the Food and Drug Administration for C1-INH in treating hereditary angioedema.

Orphan drug designation could provide the company with seven years of marketing exclusivity for its C1-INH product as a treatment for hereditary angioedema in the United States, officials said.

Hereditary angioedema is a genetic disorder characterized by recurrent attacks of inflammation affecting the hands and feet, the face, the abdomen and the larynx. The inflammation can be disfiguring, debilitating, or, in the case of laryngeal attacks, life-threatening. About 6,000 people in the United States are estimated to have the disease, officials said.

Lev is a New York City biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.