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EMA starts rapid review of Shire’s HAE antibody

The EU medicines regulator is expected to make a verdict in 150 days


Shire could be months away from its first regulatory approval for hereditary angioedema (HAE) candidate lanadelumab as the EMA starts an accelerated review of the drug.

Lanadelumab (SHP643) is also being assessed by Health Canada under a priority review application, and was submitted to the FDA last month. The EMA accelerated review means a verdict is due in 150 days rather than the usual 210, setting up a possible approval in the summer.

The antibody - which targets and inhibits plasma kallikrein - is intended as a treatment for the prevention of angioedema attacks in patients 12 years and older with HAE, a rare and sometimes life-threatening inherited disease characterised by recurrent swelling of extremities, gastrointestinal tract and upper airways.

All the applications are based mainly on data from four clinical trials, including the phase III HELP study which showed that a subcutaneous administration of a 300mg dose of lanadelumab every two weeks resulted in an 87% reduction in the mean frequency of HAE attacks overall, according to Shire. After patients were maintained on the therapy the benefit seemed to be even better with a 91% reduction in attacks and nearly eight out of ten patients attack-free.

Shire is already a major player in HAE treatment, thanks largely to its acquisition of Dyax Corp for $5.9bn in 2015, which also gave it lanadelumab. Its current portfolio consists of Cinryze (C1 inhibitor [human]), an intravenous drug used to prevent HAE attacks, Firazyr (icatibant) which is used to treat acute attacks in adults and Kalbitor (ecallantide), also for acute attacks. The latter was withdrawn from the market in Europe in 2011 but is still on sale in some countries.

Shire total HAE sales grew 23% to $1.43bn last year, with Cinryze and Firazyr making up the bulk of that bringing in $699m and $663m respectively, and Kalbitor adding around $67m. Firazyr is facing the threat of generic competition this year and the company wants lanadelumab to help plug that gap.

As a simple-to-administer injection lanadelumab is a natural successor to Cinryze and other HAE therapies, and Shire notes that it requires around 75% fewer shots than other preventive drugs. Analysts have suggested the drug could make $2bn a year at peak. Other approved treatments for HAE include CSL Behring’s Berinert and Pharming’s Ruconest.

Article by
Phil Taylor

29th March 2018

From: Sales



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