Kamada withdraws MAA for inhaled ATT

Kamada Ltd. (Tel Aviv:KMDA; NASDAQ:KMDA) said it withdrew its MAA for inhaled alpha-1 antitrypsin (AAT-IH, aerosolized alpha-1 antitrypsin) to treat alpha-1 antitrypsin (AAT; A1AT; SERPINA1) deficiency following discussions with EMA. According to the company, EMA said that an "overall positive conclusion" could not be reached based on a post hoc data analysis and that an additional trial would be required.

The MAA was based on a 168-patient European Phase II/III trial that missed the primary endpoint of improving time to first exacerbation at 1 year vs. placebo. The company said lung function parameters in the study showed a significant treatment effect in the reduction of the inflammatory injury to the lung (see BioCentury, May 19, 2014)...