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Shire finally bags EU approval for rare disease drug Natpar

Becomes first licenced treatment for hypoparathyroidism in Europe

ShireShire is celebrating an EU approval for its hypoparathyroidism treatment Natpar, two years after getting a green light for the drug in the US.

Natpar - which is sold as Natpara in the US - has been given a conditional approval by the European Medicines Agency and becomes the first and only licenced recombinant human parathyroid hormone therapy for chronic hypoparathyroidism, a rare endocrine disease that can cause a range of symptoms including eye, skin and muscle problems.

Shire's drug should only be used for patients who cannot be adequately controlled with standard therapy with calcium and vitamin D supplementation alone according to the EMA. The company had been hopeful of approval last year, so the green light comes as something of a relief and bolsters its ambition to become the leading rare disease therapy company with sales of $20bn a year by 2020.

Natpar was one of the primary reasons Shire forked out $5.2bn to buy NPS Pharma in 2015 just before the FDA gave its go-ahead for the new therapy, which analysts have predicted could make between $650m and $1bn by the middle of the next decade.

EU approval takes Shire a step closer to achieving that goal, and it still has a long way to go. Sales of Natpara in the US were $85m last year, which was a sizeable increase on the prior year but pretty much in line with expectations.

The EU conditional marketing authorisation is based on the results of the phase III REPLACE trial, which showed that Natpar was able to maintain serum calcium levels while reducing oral calcium and active vitamin D supplemental doses.

"Chronic hypoparathyroidism can carry a significant disease burden, and some patients are not well-controlled, showing fluctuations in their serum calcium levels," said Prof Maria Louisa Brandi, a specialist in endocrine and metabolic diseases based at the University of Florence in Italy.

Rare disease therapies now account for around two-thirds of Shire's turnover since it completed a $32bn acquisition of Baxter spin-out Baxalta last year and pulled out of some areas such as biosimilars and RNA-based drugs.

Article by
Phil Taylor

26th April 2017

From: Regulatory

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