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Treatment for hyperkalaemia receives European marketing approval recommendation

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Treatment for hyperkalaemia receives European marketing approval recommendation

Treatment for hyperkalaemia receives European marketing approval recommendation
May 19
15:24 2017

Veltassa (patiromer), developed by Relypsa, has received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of hyperkalaemia.

“We are very pleased with CHMP’s decision,” said Dr Behruz Eslami, head of global regulatory affairs at Vifor Pharma. “This positive opinion means that we are much closer in our efforts to give hyperkalaemia patients in Europe an option for the long-term treatment of their life-threatening condition.”

The recommendation has been based on a clinical development programme that includes the Phase III OPAL-HK study, Phase II AMETHYST-DN trial and an open-label, uncontrolled, Phase I study.

 

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