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FDA approves Shire drug for rare swelling disorder

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(Reuters) – The U.S. Food and Drug Administration on Thursday approved a first of its kind drug from Shire Plc <SHP.L> to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.

The drug, Takhzyro, is expected to bring in blockbuster sales for Shire, and is important to Japan’s Takeda Pharmaceutical Co Ltd <4502.T>, which plans to buy the Dublin-based rare disease specialist for $62 billion.

The monoclonal antibody, previously known by its chemical name lanadelumab, was approved to treat patients with types I and II hereditary angioedema (HAE), a disease that affects about 1 in 50,000.

There are only a handful of treatments available for HAE, including some from Shire. The disease affects people who have low levels of a certain protein and results in episodes of severe swelling in different areas such as the stomach, limbs, face and throat.

(Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)

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