By Dhirendra Tripathi
Investing.com – Apellis Pharmaceuticals (NASDAQ:APLS) shares surged nearly 20% Monday after the U.S. Food and Drugs Administration gave its approval Friday for its therapy that increases hemoglobin in patients and reduces the need for blood transfusion.
The company claims that the therapy, Empaveli, is the first and only targeted C3 therapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria. C3 is a protein that contributes to immunity and triggers a response in the body when it is attacked by foreign elements or pathogens like virus and bacteria.
Empaveli is approved for use in adults with PNH who are treatment naïve as well as patients switching from the C5 inhibitors Soliris® (eculizumab) and Ultomiris® (ravulizumab).
Apellis was able to prove that the therapy is superior to Soliris in treating hemoglobin level. Soliris is an existing prescription medicine for the disease.
The prescribing information for Empaveli contains a boxed warning. Empaveli may increase the risk of meningococcal and other serious infections caused by encapsulated bacteria.