Regulatory ScPharmaceuticals Furosemide injection for heart failure approved by the...

ScPharmaceuticals Furosemide injection for heart failure approved by the FDA

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Furosemide injection 80mg/10mL by scPharmaceuticals has been approved by the FDA for use by chronic heart failure patients for treatment at home. The drug’s exclusive formula of furosemide is given using an On-Body Infusor.

According to ScPharmaceuticals, this approval will add to the already available options catering to deteriorating heart failure. This condition affects over 6M United State residents and the care cost goes over $30B per year according to the company. The injection is meant for people suffering from New York Heart Association Class II/III chronic heart failure who face congestion caused by an excess of fluid.

Ohio State professor and board member of the company, William Abraham said, “This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of intravenous diuretics, which typically requires admission to the hospital.” He also said that the FDA approval of the drug is substantial and will enable patients to avail the treatment at settings other than that of the hospital. 

The title of the first and only self-administered treatment that is used for congestion due to chronic health failure belongs to Furoscix. It is used in subcutaneous doses of a pre-programmed system that is worn by the patient.

The treatment reduces the fluid overload in patients that have NYHA Class II/III chronic heart failure and are somewhere between not requiring hospitalization and not particularly responding to oral diuretics.

The treatment was compared to standard care in a randomized phase 2 AT HOME-HF study that had 51 participants that had chronic heart failure, congestion, and did not respond well to diuretics. The trial displayed a 37% reduced risk of heart failure hospitalization in patients who were treated with the injection as compared to people in standard care over a period of 30 days.

Key secondary outcomes revealed that furosemide leads to a larger reduction in the mean body weight of patients from 2.8 at starting point to 0.8 on day 3 (P=0.035). Progresses in other metrics were also noticed, such as the mean 5-item dyspnea score was enhanced from -0.5 to 0.1 on day 3 (P= 0.019).

The injection is specified as not to be used in cases of emergency or in acute pulmonary edema patients. Other contraindications include anuria, hepatic cirrhosis or ascites, or hypersensitivity to furosemide.

John Tucker, the president and CEO of ScPharmaceuticals said that congestion because of deteriorating heart failure is a common reason why patients over the age of 65 are admitted to the hospital and this approval will be beneficial for such patients, beyond 7M in number in the country, as they could use the treatment in the comfort of their own homes.

Furoscix is finally approved to be in the market as this approval comes after the drug was rejected by the FDA twice before.

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