Kamada (KMDA)

[midastouch017]

FDA not on board with Kamada's inhaled AAT; shares down 4%

Aug. 28, 2017 3:59 PM ET|About: Kamada Ltd (KMDA)|By: Douglas W. House, SA News Editor
Kamada Ltd. (KMDA -4.4%) says it received a letter from the FDA regarding its proposed protocol for a Phase 3 registration trial for its inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

The feedback was not what the company wanted to hear. The agency stated that it "continues to have concerns and questions" about the safety and efficacy of inhaled AAT.

The company intends to continue its dialogue with the regulator.

As previously disclosed, on July 18, 2017, Kamada Ltd. (the “ Company ”) submitted to the U.S. Food and Drug Administration (the “ FDA ”) a proposed Phase 3 protocol for the Company’s “Alpha-1 Proteinase Inhibitor (human) Inhalation; Kamada-API for Inhalation” product candidate (“ Inhaled AAT ”).

In response to the study protocol and previous submission, the FDA issued a letter to the Company stating that it continues to have concerns and questions about the safety and efficacy of the Inhaled AAT. As previously disclosed, the Company will need to receive authorization from the FDA in order to proceed with the clinical development of Inhaled AAT in the United States, including its proposed Phase 3 trial.

The Company continues to engage in dialogue with the FDA on the concerns and questions it has raised and to discuss and evaluate next steps to proceed with the clinical studies.