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On April 28, Calliditas announced that its new drug application (NDA) for Nefecon (Budesonide Sustained Release Capsules) has been accepted by the FDA for the treatment of IgA nephropathy.
IgA nephropathy (IgAN) is a serious progressive renal autoimmune disease, which is an important cause of end-stage renal disease (ESRD).
Nefecon is a sustained-release capsule developed by Calliditas using TARGIT technology to release budesonide only at the origin of lgA nephropathy in the lower part of the small intestine, the Pyle's collective lymph node area.
Nefecon preparation structure
Nefecon preparation structureThe advantages of this drug design are: ① The three-layer coating can make the drug targeted, realize that budesonide is continuously concentrated in the intestinal collecting lymph nodes, and locally inhibit the production of mucosal leAl antibodies, thereby reducing disease-causing immune complexes in the blood The generation.
Nefecon only releases the drug in the ileum
Nefecon only releases the drug in the ileumCalliditas submitted a marketing application to the FDA on March 15, 2021, based on the positive results of Part A of a key Phase III clinical study code-named NefIgArd.
The results of Part A of the study showed that after 9 months of treatment, the urine protein/creatinine ratio (uPCR) of the Nefecon group decreased by an average of 31% compared with the baseline value, while the placebo group only decreased by 5%.
