BRIEF—US FDA approves new label for Veltassa

Swiss drugmaker Vifor Pharma says that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its Veltassa (patiromer), for the treatment of hyperkalemia, with or without food.

The updated label may allow for increased dosing flexibility for patients with hyperkalemia, the company noted.

Veltassa was developed by US biotech firm Relypsa, which Vifor acquired in a $1.53 billion deal in 2016.

The label update is based on results from the Phase-IV TOURMALINE study, which showed no statistically- significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L).

"Since the US approval of Veltassa two years ago, we have seen how the availability of this medicine has been able to raise awareness for a disease that is often asymptomatic and potentially fatal, to empower patients in managing their disease and to significantly transform how doctors treat it," said Stefan Schulze, president of the Vifor Pharma Group executive committee and chief operating office.

Veltassa was approved by the US FDA for the treatment of hyperkalemia in October 2015 and has been available to patients in the USA since December 2015.

Veltassa was approved in the European Union, Norway, Iceland and Liechtenstein in July 2017, and in Switzerland and Australia in December 2017.

Veltassa is currently available to patients in Norway, the UK, Denmark and Germany. Other applications are planned in other markets worldwide.