Kamada Is Pursuing US Market With Its Aerosolized AAT

NESS ZIONA, Israel—Kamada, a bio-pharmaceutical company, has submitted its clinical development program to the FDA for its flagship drug, Alpha-1 Antitrypsin (AAT) with its aerosolized (inhaled) form for the treatment of Congenital Emphysema caused by Alpha-1 Antitrypsin Deficiency (AATD). The company plans to commence clinical development in the US concurrently with the trials already underway towards registration in Europe.

“The potential number of AATD subjects worldwide is estimated by the US Alpha -1 patients’ organization at approximately 200,000. According to an independent survey, only 5,000 of these are currently treated. We therefore see a significant potential in the treatment of AATD with the aerosolized AAT drug. The cost of treatment with the aerosolized version is expected to be lower than with intravenously administered AAT. Furthermore, there is continuously growing clinical evidence from all over the world indicating that the rationale in treating Congenital Emphysema with AAT is also valid for treating other respiratory diseases, such as: Cystic Fibrosis, and possibly others. Therefore, development of the product for additional indications is underway. We are collaborating with the leading worldwide physicians in this field,” said Kamada’s CEO, David Tsur.

According to John Walsh, President of US Alpha One Foundation, “the US Alpha-1 community is extremely excited about this submission and the progress made in Kamada’s European trials for aerosolized delivery of augmentation therapy. The Alpha-1 Foundation has prioritized the development of aerosolized AAT and is committed to supporting this application.”

To read full press release, click here.