U.S. FDA approves ScPharmaceuticals’ heart failure therapy
Oct 10 (Reuters) – The U.S. Food and Drug Administration on Monday approved ScPharmaceuticals Inc’s (SCPH.O) therapy to treat congestion of heart due to fluid overload among patients with heart failure.
The approval marks the end of a long path to the market for the therapy, Furoscix, after the regulator rejected it twice.
The drug is delivered via an on-body infusor. Heart failure is a long-term condition in which the heart cannot pump enough blood to meet the body’s needs all the time.
There are more than seven million heart failure patients in the United States, and they will now be able to self-administer the treatment at home, Chief Executive John Tucker said in a statement.
Shares of the company, which expects to launch the treatment in the first quarter of 2023, rose 2.2% to $5.1 in premarket trading.
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