Evolocumab, Amgen

Drug: Evolocumab
Company: Amgen
Phase: Phase III
Class: Anti-proprotein convertase subtilisin-like kexin type 9 (PCSK9) MAb
2020 sales: $1.09 billion
Net present value: $3.5 billion

Amgen ($AMGN) has been racking up one Phase III success after the next on evolocumab, a PCSK9 blocker that has been clearing LDL cholesterol from the blood. Depending on who you talk to, this could be a $10 billion drug class in its own right. But the FDA has made it abundantly clear that it expects to see a mountain of human data on efficacy and safety before it agrees to provide an OK for marketing the therapy to a large audience. A regulatory filing is expected soon, which will help Amgen clarify its position in a tight race that includes a very successful Sanofi/Regeneron ($REGN) partnership as well as Pfizer ($PFE), which is bringing up the rear with a trademark case of slow-motion R&D syndrome. One potential stumbling block: neurocognitive impairment. Investors experienced a bad case of vertigo after Sanofi ($SNY) recently revealed that the FDA wants everyone in the field to track cases of "fuzzy thinking" among patients. Cholesterol drugs have been linked to confusion before, but generally it's been quickly treated by getting the patients off the drug.

For more:
Sanofi, Regeneron pay $67M for a shortcut in the blockbuster PCSK9 race with Amgen
Amgen pads its PCSK9 lead with latest data on a potential blockbuster
Tomorrow's cardio blockbusters: Inside 'the next big leap' in controlling cholesterol
Amgen's PCSK9 drug slashes 'bad' cholesterol in PhIII, stoking blockbuster hopes

Evolocumab, Amgen

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