FDA approves Glassia for treating Alpha 1 deficiency

NewsGuard 100/100 Score

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.

Source:

Kamada

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Study reveals daily food environment exposure shapes fast food habits