NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada Ltd. (NASDAQ:KMDA) (TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today provides a clinical/regulatory update.
•Kamada has held encouraging pre-submission meetings with its European rapporteur and co-rapporteur with regard to the Company’s Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its inhaled alpha-1 antitrypsin (AAT) for the treatment of alpha-1 antitrypsin deficiency (AATD). The co-rapporteurs advised that they would consider the entire study data once submitted, including post hoc analysis and will not reject the application simply because the primary endpoint of the study was not met. They agreed that the application fulfills the requirements relating to unmet medical need and benefit to public health and that it may meet the scope of Conditional Approval (CA) if the company convincingly proves the positive benefit-risk balance of the product, by the time of MAA filing. The co-rapporteurs have requested the addition of supplemental data analyses that may address the benefit-risk balance and support the already available safety and efficacy data. Kamada has begun conducting the additional data analyses and plans to file the MAA with the EMA in Q4 2015. In addition, the Company expects to present the complete data set from the Phase II/III clinical study at the upcoming American Thoracic Society Annual Meeting in May 2015.
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•Kamada has held encouraging pre-submission meetings with its European rapporteur and co-rapporteur with regard to the Company’s Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its inhaled alpha-1 antitrypsin (AAT) for the treatment of alpha-1 antitrypsin deficiency (AATD). The co-rapporteurs advised that they would consider the entire study data once submitted, including post hoc analysis and will not reject the application simply because the primary endpoint of the study was not met. They agreed that the application fulfills the requirements relating to unmet medical need and benefit to public health and that it may meet the scope of Conditional Approval (CA) if the company convincingly proves the positive benefit-risk balance of the product, by the time of MAA filing. The co-rapporteurs have requested the addition of supplemental data analyses that may address the benefit-risk balance and support the already available safety and efficacy data. Kamada has begun conducting the additional data analyses and plans to file the MAA with the EMA in Q4 2015. In addition, the Company expects to present the complete data set from the Phase II/III clinical study at the upcoming American Thoracic Society Annual Meeting in May 2015.
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