APPROVALS

The FDA has approved furosemide (Furoscix) injections as an at-home treatment for patients with chronic heart failure, suffering from congestion.

It is administered through a system known as an On-Body Infuser.

According to scPharmaceuticals, heart failure affects more than six million people in the US and costs over $30bn annually, so another treatment option is hugely positive news. The new treatment is approved for treating congestion caused by fluid overload in patients with chronic heart failure who do not need hospitalisation, but have not responded to oral diuretic treatments.

Furoscix lowers fluid overload in patients to treat their congestion, and it is the only self-administered loop diuretic currently on the market. It is administered subcutaneously using a wearable, pre-programmed delivery device. 

In the phase 2 trial, 51 patients were recruited, and the new treatment was compared with standard care over a 30-day period. Those treated with furosemide showed a 37% lower risk of hospitalisation from heart failure when compared to those treated with the traditional method.

John Tucker, President and Chief Executive Officer of scPharmaceuticals, said, “Congestion due to worsening heart failure is one of the most common causes of hospital admissions in patients over 65, and today’s approval of Furoscix represents an important treatment advancement for the over 7 million heart failure patients in the US that will be able to self-administer IV equivalent diuresis at home. […] We are preparing to optimise commercialisation efforts to offer Furoscix to patients in the first quarter of next year with the goal of driving rapid patient adoption to meet the needs of the $5.9bn addressable market in the US.”