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Vifor Pharma PIVOTAL Trial Update


Vifor Pharma’s PIVOTAL trial was the first trial, according to the commercial sponsor, to assess the optimal dosing strategy of intravenous iron in patients undergoing haemodialysis, and demonstrated that exposing those patients to higher doses of iron over time significantly reduced the risk of mortality or major nonfatal cardiovascular events according to Stefan Schulze, COO Vifor Pharma Group. Recently, the Swiss biopharma sponsor updated their results as the primary endpoint—composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death—reached statistically significant superiority (P = 0.04) for the proactive, high-doze Venofer regiment compared with the low-dose Venofer group. Results are included here.

Who is Vifor Pharma Group? Founded in 2008, it was the result of the acquisition of the former Aspreva Pharmaceuticals. Under the new corporate structure, the former companies of Galencia—Vifor (International), Vifor and Potters—were merged into a fully integrated pharmaceutical company. In 2009, Galencia acquired OM Pharma, an immunology-focused venture. Galencia acquired U.S.-based Relypsa in 2016 for $1.5 billion and integrated into Vifor Pharma. Vifor Pharma has an estimated 2,650 employees and revenues of 1.4+ million CHF. Their R&D focus: 1) Iron Deficiency Therapies 2) Velphoro and 3) Other Therapies.


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