The Center for Devices and Radiological Health (CDRH) of the FDA has approved Kaneka Pharma America’s humanitarian device exemption (HDE) application for the LIPOSORBER® LA15 System to expand the indication to include adult patients with nephrotic syndrome. The LIPOSORBER® LA-15 is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a GFR > 60 ml/min/1.73m2 or the patient is post renal transplantation.
My earlier comment was relevant to the just released news the the FDA has approved the use of LDL apheresis combined alirocumab. Refer to Phase III ODYSSEY ESCAPE. Also search for actual FDA annoucement.
christian schrock MD email@example.com +1 763-923-4059 Lp(a)CARE
This news is important in the treatment of Elevated Lp(a) in that it supports the safety of using iPCSK-9 combined with LDL Apheresis for treatment of pt with elevated Lp(a). This same combined therapy for Hyperlipoproteinemia(a) is used in Europe in some pts and at this time we are treating one patient with this approach. Since Apheresis is done every other week in the US the pts Lp(a) rose)levels to the 160mg/dL baseline of Lipoprotein(a) from the 30 mg/dL achieved immediately after Apheresis. When PCSK-9 inhibitor was given after apheresis the level only returned to 70 mg/dL. Using pretreat - post treat (the simple average) as rough estimate of area above curve of reduction one finds 160-30 = 130 average over the two weeks vs 70-30 = 40. I will ask Patrick Moriarty to confirm with his patients with hyperLp(a). 2) This should give confidence to the physician who is concerned that LDL is too low. Christian Schrock firstname.lastname@example.org +1 763-923-4059 Lp(a)CARE lpacare.com