Kamada has submitted a Marketing Authorization Application for its inhaled alpha-1 antitrypsin (AAT) therapy for the treatment of AAT deficiency to the European Medicines Agency, and the filing EMA has validated the application, the company said.
Kamada CEO Amir London commented, “The submission of this application represents an important achievement that brings us one step closer to our goal of commercializing our inhaled AAT therapy for the benefit of patients suffering with AATD in Europe. The EMA has agreed to evaluate the totality of the data from our innovative Phase 2/3 study, and based upon orphan designation of the drug, prior discussions with regulators, the strength of these data, the support we get from the key opinion leaders and the patient community, and the persistent unmet need in this chronic disease, we are highly optimistic of a favorable outcome. Importantly, the combination of lung function measurements, which are the gold standard for pulmonary diseases, and symptom improvements, along with the safety profile of the product, gives us confidence these data meet the risk/benefit balance required by EMA.”
Inhaled AAT, which is delivered using a PARI e-flow nebulizer, has orphan drug designation for the treatment of CF in the US and Europe. Kamada is also developing inhaled AAT for the treatment of bronchiectasis.
Read the Kamada press release.
