Regulatory win facilitates the growing market demand for peptide therapeutics.
The US Food and Drug Administration (FDA) has approved the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9).
Merck and Co’s Lipfendra (enlicitide) cholesterol-lowering drug offers the first non-injectable PCSK9 inhibitor for patients with cardiovascular diseases.
Alongside a diet and exercise protocol, the macrocyclic peptide therapy gives adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH), an additional treatment option.
Dr Michael Davis, Acting Director of the FDA’s Center for Drug Evaluation and Research, remarked that approval of the once-daily therapy “provides an additional treatment option for adults with hypercholesterolemia and reflects the FDA’s broader commitment to supporting meaningful advances in patient access and tackling chronic diseases.”
[Approval of Lipfendra] provides an additional treatment option for adults with hypercholesterolemia and reflects the FDA’s broader commitment to supporting meaningful advances in patient access and tackling chronic diseases”
Dr Michael Davis, Acting Director of the FDA’s Center for Drug Evaluation and Research
The approval is based on clinical data that showed Lipfendra significantly reduced LDL-C levels in patients with hypercholesterolemia and atherosclerotic cardiovascular disease.
In the first trial of patients with ASCVD or at high risk for ASCVD, Lipfendra reduced LDL-C levels by an average of 56 percent at Week 24 compared with placebo. Findings from the second trial in HeFH found that Lipfendra enabled an average reduction of 59 percent.
In other developments within the cardiovascular therapeutic landscape, earlier this year the FDA authorised AstraZeneca’s Baxfendy (baxdrostat) as the first aldosterone synthase inhibitor (ASI) in combination with other antihypertensive medications for adults with hypertension.
Meanwhile, AstraZeneca has been advancing PCSK9 inhibitor oral laroprovstat in Phase III development.
As GLP-1 peptide therapies continue to dominate the market share, this week Samsung Biologics also made a significant move in the therapeutic peptide arena by agreeing to acquire PolyPeptide Group AG for $1.8 billion.
Back in March, the FDA approved Johnson & Johnson’s targeted oral peptide therapy Icotyde (icotrokinra) as the first targeted oral peptide that precisely blocks the IL-23 receptor. The treatment is indicated for plaque psoriasis and delivers complete skin clearance alongside a favourable safety profile in a once-daily pill.
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