Press release

Velphoro® (PA21) receives Positive CHMP Opinion

Friday, 27 June 2014, ↓ directly to download

Velphoro® (sucroferric oxyhydroxide) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorisation for the 28 EU countries for the control of serum phosphorus levels in adult patients with Chronic Kidney Disease (CKD) on haemodialysis (HD) or peritoneal dialysis (PD). The final decision on the approval by the European Commission is expected in autumn 2014.

Velphoro® (previously known as PA21) is an iron-based, calcium-free, chewable phosphate binder. The CHMP’s positive opinion was based on a pivotal Phase III study which met its primary and secondary endpoints. The study demonstrated that Velphoro® successfully controls hyperphosphatemia with fewer pills than sevelamer carbonate, the current standard of care in patients with CKD on dialysis1. The average daily dose to control hyperphosphatemia was 3.3 pills per day after 52 weeks.

Continue

Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).

Contact

Julien Vignot

Julien Vignot

Head Investor Relations


Galenica Ltd.

Investor Relations
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 81 11
Fax:
+41 58 852 81 12

Christina Hertig

Christina Hertig

Head of Corporate Communications


Galenica Ltd.

Corp. Communications
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 85 17
Fax:
+41 58 852 85 58

Send link

Send as link



Links