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.
Hereditary angioedema (HAE) is a genetic disorder caused by a deficiency of C1 inhibitor, a circulating plasma protein. Patients with C1 inhibitor deficiency experience recurrent and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Lev is the only company developing both acute and prophylactic indications for the comprehensive treatment of HAE in the US.
Joshua Schein, Lev’s CEO, said: “Today’s announcement marks the achievement of another important milestone for Lev. 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.”