Momentum Builds For PCSK9 Class, But Proof Of Safety Still Thin
Amgen’s Phase II program for its PCSK9 inhibitor AMG 145 impresses when it comes to lowering cholesterol. But the studies were only 12 weeks long and the bigger test for monoclonal antibodies like AMG 145 and Sanofi/Regeneron’s rival REGN727 is proof of longer-term safety in bigger trials.
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PCSK9 inhibitor alirocumab outperforms Merck’s Zetia as a monotherapy in first Phase III trial reported, a result that has relevance for the large population of statin-intolerant patients, according to the drug’s sponsors.
Regeneron/Sanofi and Amgen stress the strengths of the Phase III PCSK9 development programs at the American College of Cardiology annual meeting. The mechanism of action holds appeal, but development is taking place at a time of skepticism about surrogate CV markers, following failed trials of other drugs.
The big biotech is investing heavily in two late-stage drugs – one for high cholesterol and the other for osteoporosis – that will test its ability to expand its specialty marketing savvy into primary care markets. Denosumab, launched in 2010 for osteoporosis under the brand name Prolia, was a first step, but investors see bigger opportunities ahead.