Advanced Life Sciences (ADLS) has received a complete response letter from FDA, regarding its New Drug Application (NDA) for Restanza (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP).
Reportedly, FDA indicated that they cannot approve the application for Restanza in its current form and that to gain approval, an additional clinical data is required to demonstrate efficacy. ADLS plans to comply with the Agency’s recommendations and continue to pursue approval of Restanza.
Moreover, ADLS is developing a protocol for an additional phase 3 trial that is designed to satisfy FDA’s request for additional efficacy information.
In addition to developing Restanza as a potential treatment for CAP, the company has received a $3.8 million contract from the Department of Defense via the Defense Threat Reduction Agency (DTRA). It will be used to fund NDA-enabling studies to evaluate Restanza’s efficacy against bioterror agents such as tularemia, plague and melioidosis.
Michael Flavin, chairman and CEO of ADLS, said: ADLS appreciates the FDA’s response to the Restanza NDA and is committed to complying with the Agency’s requirements to conduct a clinical program that could lead to approval in CAP. We are, however, disappointed that the timing of the new draft CAP guidance issuance had an unfortunate impact on the outcome of our NDA. Looking ahead, we intend to design a study that complies with the new draft CAP guidance and we will work with the Agency to determine the optimal pathway to registration.
We remain encouraged by the supportive comments made by AIDAC committee members in June relative to their positive view of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the Company pursue further development. We continue to receive strong support from our commercial partner Wyeth and intend to work in close collaboration with them as we implement our clinical program, he added.