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Vifor wins European approval for Veltassa

European Commission approves the drug to treat hyperkalaemia


The European Commission (EC) has approved Vifor’s Veltassa (patiromer) to treat adults with hyperkalaemia, a potentially life threatening condition which can cause cardiac arrest and muscle paralysis.

The go-ahead is a significant milestone for Vifor Pharma Group - who acquired Veltassa from Relypsa - as it marks the drug’s first regulatory approval outside the US.

Since its US launch in 2015, 33,000 patients have been treated with the product to date and the pharma group said it was “encouraged by the growing acceptance and uptake of Veltassa by clinicians and patients”.

Scott Garland, president of Relypsa, said: “We look forward to working with our colleagues at Vifor Pharma Group to help bring Veltassa to patients in Europe, where a new daily treatment for hyperkalaemia is needed.”

In the EU, Veltassa is indicated to treat adults with hyperkalaemia, including those who develop the disease as a side effect while being treated with renin angiotensin aldosterone system (RAAS) inhibitor therapy due to heart failure and/or chronic kidney disease.

RAAS inhibitors can also lead to elevated potassium levels, which can lead to organ failure, however researchers have found patiromer can reduce potassium levels.

Marco Windisch, general manager for Vifor Fresenius Medical Care Renal Pharma UK, said: “For nearly 60 years there have been no new treatments specifically developed and indicated for persistent elevated potassium available in Europe.

“The European Commission licensing of patiromer in hyperkalaemia will help many patients better manage elevated potassium and get the maximum benefit from their life preserving RAAS inhibitor therapy.”

Relypsa plans to submit Veltassa applications in other markets worldwide and the product is currently under regulatory review in Switzerland and Australia.

However, there’s potential competition on the horizon from AstraZeneca, which has a positive opinion the Committee for Medicinal Products for Human Use (CHMP) for its hyperkalaemia drug Lokelma (sodium zirconium cyclosilicate) in February.

This should have put Lokelma on course for full European approval by now, but that looks to be on hold after the manufacturing site for its active substance was found by the US FDA not to be in accordance with good manufacturing practice. The EMA said in April it would “consider the potential impact of this new information on the adopted CHMP opinion”.

Article by
Gemma Jones

26th July 2017

From: Regulatory



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