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Shire receives FDA nod for self-infusion of Glassia

The company has also struck a deal with Pfizer to expand its GI portfolio

ShireShire's emphysema therapy Glassia has received FDA approval for an expanded label, marking the first time that patients can self-infuse at home.

Glassia, an alpha-1 proteinase inhibitor, is licensed for the treatment of adults with emphysema due to severe alpha-1 antitrypsin (AAT) deficiency, a protein that helps protect lung tissue from damaging enzymes released by white blood cells.

Originally approved in 2010, Shire and partner Kamada's therapy is the only liquid, ready-to-use augmentation product for AAT deficiency currently on the market.

Emphysema patients receiving Glassia will be able to avoid frequent hospital visits and carry out their drug infusions at home, once they have received appropriate training in how to do so.

Blaine Forshage, Shire's US immunology franchise lead, commented that patients with AAT deficiency “are managing a challenging disorder that may require regular regimented care”.

“For these patients” he added, “our company strives to find ways to provide them with more choices and flexibility in their treatment regimen”.

Chronically under-diagnosed, only an estimated 10% of the 100,000 people living with AAT deficiency in the US have received proper treatment.

Shire expands GI portfolio with Pfizer deal
Meanwhile, Shire has also expanded its gastrointestinal portfolio by in-licensing an investigational biologic PF-00547659 from Pfizer.

The drug has undergone phase I and II trials for the treatment of moderate-to-severe inflammatory bowel disease (IBD), and is due to begin phase III trials shortly.

Howard Mayer, head of clinical development at Shire, said that the transaction “fits with Shire's commitment to advancing research and development in select specialty areas, including areas of unmet patient need for gastrointestinal conditions such as IBD”.

“We look forward to continuing the development of PF-00547659, a biologic that will benefit from our experience in IBD and across the gastrointestinal space”, he added.

IBD encompasses ulcerative colitis and Crohn's disease, chronic diseases characterised by inflammation of the intestine. Approximately 3.5 million people across Europe, Japan and the US are thought to suffer from the disease. 

Article by
Rebecca Clifford

17th June 2016

From: Regulatory



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