FDA approval of the first-in-class PCSK9 inhibitors evolocumab and alirocumab in summer 2015 was met with a full spectrum of response, from elation among advocates for patients with variants of familial hypercholesterolemia to grave reservations among scientists who feel that LDL cholesterol level is not a reliable surrogate for cardiovascular benefit. Results are remarkable -- a dose-dependent reduction in LDL-C (up to 70%) occurred at between 4 and 14 days with a 2 to 8+ week delay in return to baseline with each agent.
Whether you agree or disagree with the FDA decision, understanding the PCSK9 antibodies and how they work is worth the time it will take to view the short primer we offer in the slides above.
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2. Praluent [package insert]. Accessed October 22 2015 at: http://products.sanofi.us/praluent/praluent.pdf
3. Repatha [package insert]. Accessed October 22 2015 at: http://pi.amgen.com/united_states/repatha/repatha_pi_hcp_english.pdf
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