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news.Kamada has received FDA approval for Glassia (Alpha 1 Proteinase inhibitor, also known as Alpha-1-Antitrypsin (AAT) for the treatment of Alpha 1 deficiency (AATD)
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Kamada claimed that Glassia is now the first and only liquid Alpha- 1-Proteinase Inhibitor worldwide available liquid, ready to use, Alpha- 1-Proteinase Inhibitor on the market.
Kamada said that the FDA approval for Glassia is based on the review of its biological license application (BLA) which was submitted in May 2009.
The FDA has reviewed Kamada’s clinical development as well as auditing and approving Kamada’s manufacturing facility, quality assurance and controls.
David Tsur, CEO of Kamada, said: “With this 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, said: “We are delighted to welcome Kamada to the US market. Glassia offers a new and an innovative therapeutic alternative for our patients and we look forward to the company’s entry into our patient community.”