Jul 7 2010
Kamada (TASE:KMDA), today announced that the United States Food and Drug Administration (FDA) has approved GlassiaTM (Alpha 1 Proteinase inhibitor, also known as Alpha-1-Antitrypsin (AAT) for the treatment of Alpha 1 deficiency (AATD). GlassiaTM is now the first and only liquid Alpha- 1-Proteinase Inhibitor worldwide available liquid, ready to use, Alpha- 1-Proteinase Inhibitor on the market.
“We are delighted to welcome Kamada to the US market. GlassiaTM offers a new and an innovative therapeutic alternative for our patients and we look forward to the company's entry into our patient community.”
The FDA approved GlassiaTM following review of Kamada's Biological License Application (BLA) submitted in May 2009. The FDA's review included Kamada's clinical development as well as auditing and approving Kamada's manufacturing facility, quality assurance and controls.
David Tsur, Chief Executive Officer of Kamada said, "We are very proud with this achievement. This success belongs to each one of the company's employees. With this unique product, Kamada is able to offer the US Alpha-1 patients a new liquid, ready- to- use drug that may ease their therapy routine and provide an additional high quality product in the US market for the benefit of this community.
We are committed to the Alpha-1 patient community and take great pride in further developments of our second generation product, an inhaled Alpha- 1-Proteinase Inhibitor currently in stage 2-3 clinical development."
John Walsh, President of the US Alpha-1 Foundation congratulated Kamada, "We are delighted to welcome Kamada to the US market. GlassiaTM offers a new and an innovative therapeutic alternative for our patients and we look forward to the company's entry into our patient community.
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