One analysis showed the addition of Repatha to statin therapy improved clinical outcomes with significant reduction of CV events in patients with a history of PAD. Because of their greater baseline risk of CV events, there was a numerically greater absolute risk reduction at 2.5 years in patients with PAD (ARR 4.1%, 95% CI 2.5-6.7) relative to those without PAD (ARR 1.5%, 95% CI 0.7-2.2).
A separate analysis investigated the efficacy of Repatha in high-risk patients who have experienced a prior heart attack.
In that analysis, the ARR was greater (~3% ARR over three years) in patients with a history of heart attack within two years compared to those whose heart attack was more than two years past (ARR 1%).
No new safety concerns were identified in these analyses.
Repatha (evolocumab) is a human monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9) and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear low-density lipoprotein from the blood, thereby lowering circulating LDL levels.
Repatha is approved in more than 50 countries, including the US, Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.
Amgen is dedicated to advancing care and improving the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.
The company's research utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Lighthouse Pharmaceuticals announces receipt of USD49.2m grant from NIA for LHP588 study
Bio-Thera and STADA expand biosimilars partnership to include tocilizumab
Shilpa Medicare secures approval for NAFLD therapy NorUDCA in India
Remegen's Telitacicept meets Sjogren's syndrome Phase III trial's primary endpoint
PainReform acquires majority stake in LayerBio to advance dropless cataract surgery therapy
Seragon launches Enlivien sleep and longevity optimiser
Insmed's BRINSUPRI (brensocatib) non-cystic fibrosis bronchiectasis treatment approved by US FDA
Fosun Pharma agrees XH-S004 overseas licensing deal
Novartis reports positive Phase III results for ianalumab in Sjögren's disease