Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Lev Pharmaceuticals' lead investigational product C1-INH has been granted fast track status by the FDA for the treatment of hereditary angioedema.
Subscribe to our email newsletter
Hereditary angioedema (HAE) is a genetic disorder characterized by recurrent attacks of inflammation affecting the extremities (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.
“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 HAE,” said Dr Joshua Schein, CEO of Lev Pharmaceuticals. “This is the only clinical trial underway, to our knowledge, for the development of a prophylactic treatment for this debilitating and life-threatening condition.”
The fast track programs of the FDA 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.
Lev Pharmaceuticals initiated its phase III 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 HAE. The second part of the phase III study is specifically examining the ability of C1-INH to prevent such inflammatory attacks.