EU CHMP recommends approval of Veltassa (patiromer) for the treatment of hyperkalaemia- Vifor Fresenius

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Veltassa (patiromer), from Vifor Fresenius, intended for the treatment of hyperkalaemia. Veltassa will be available as a powder for oral suspension (8.4 g, 16.8 g and 25.2 g).

Veltassa increases faecal potassium excretion by binding potassium in the lumen of the gastrointestinal tract, resulting in a reduction of serum potassium levels. The benefit with Veltassa is its ability to lower serum potassium levels. The most common side effects are hypomagnesaemia, constipation, diarrhoea, abdominal pain and flatulence.

The European submission for Veltassa is supported by data from a comprehensive clinical development program that included the pivotal Phase III OPAL-HK study, which was conducted under a FDA Special Protocol Assessment and evaluated Veltassa in hyperkalemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors. It also included the Phase II AMETHYST-DN trial, which evaluated the use of Veltassa over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors, and an open-label, uncontrolled, Phase I study that evaluated the onset-of-action of Veltassa in hyperkalemic CKD patients.