Arrowhead Pharmaceuticals Inc. (ARWR) announced that the FDA has approved REDEMPLO for adult patients with familial chylomicronemia syndrome.
Familial chylomicronemia syndrome (FCS) is a rare genetic disorder, with patients typically having triglyceride levels 10 to 100 times higher than normal, placing them at substantially higher risk of recurrent and potentially fatal pancreatitis.
REDEMPLO (plozasiran) is a small interfering RNA (siRNA) therapy using Arrowhead's proprietary TRiM platform to reduce triglycerides by silencing the disease-driving genes. Administered as a convenient 25 mg subcutaneous injection once every three months, it provides patients with a self-administered treatment option.
The FDA approval was based on results from a Phase 3 trial, dubbed PALISADE, a placebo-controlled study that evaluated the efficacy and safety of REDEMPLO in adults diagnosed with FCS.
The results demonstrated that REDEMPLO significantly reduced triglyceride levels from baseline and lowered the numerical incidence of acute pancreatitis compared to placebo.
Safety data indicated that the regimen was generally manageable, with the added advantage of being suitable for outpatient administration and self-injection, according to the company.
Data from the PALISADE study will be presented at upcoming scientific meetings, providing further visibility into the clinical impact of REDEMPLO.
This approval marks Arrowhead's first FDA-approved medicine, representing a major milestone as the company transitions into commercial-stage operations. REDEMPLO will be available in the U.S. before the end of the year.
ARWR has traded in the range of $9.57 to $43.69 over the past year. The stock closed yesterday's trading at $40.47, up 0.08%.
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