22 June 2017 - Kamada today announced that the company has withdrawn the marketing authorisation application for its proprietary inhaled alfa-1 anti-trypsin therapy for the treatment of alfa-1 anti-trypsin Deficiency with the EMA. 

Following extensive discussions with the EMA during recent months, Kamada concluded that the EMA does not view the data submitted to date as sufficient for approval of the MAA, and that the supplementary data needed for approval requires an additional clinical trial.

While the post-hoc data provided by the Company from the European clinical trial showed a statistically significant and clinically meaningful improvement in lung function, the EMA was of the opinion that an overall positive conclusion on the effect of inhaled AAT to treat AATD could not be reached based on that post-hoc analysis, and that the treatment of AATD patients with inhaled AAT should be further evaluated in the clinic in order to obtain comprehensive long-term efficacy and safety data.

Read Kamada press release