The US Food and Drug Administration (FDA) of the United States has approved the on-body infusor ‘Furoscix’ for congestive heart failure developed by scpharmaceuticals. With this approval, Furoscix becomes the first self-administered, and subcutaneous loop diuretic for people with worsening heart failure.
This infusor delivers generic furosemide that relieves fluid retention and swelling, which causes heart failure and other conditions such as kidney and liver disease. This therapy provides the equivalent of what a patient would receive by way of an IV at a hospital.
According to the company, there are more than 7 million people with heart failure in the United States, and many are prone to hospitalization for congestion as they have become resistant to oral diuretics.
John Tucker, CEO of scPharmaceuticals said that it will launch Furoscix therapy in the first quarter of 2023 with the aim of driving rapid patient adoption to meet the needs of the 5.9 billion dollars addressable market in the United States.
The clinical study of Furoscix therapy showed 99.6 percent bioavailability equivalence with IV, with a similar diuretic profile measured by sodium excretion and urine production. The company believes the therapy can change the paradigm of how patients with heart failure with congestion are treated, and it also has potential to become a new standard of care.