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Sanofi and Amgen cholesterol drugs shine

pharmafile | March 16, 2015 | News story | Sales and Marketing Amgen, PCSK9, Repatha, Sanofi, alirocumab, evolocumab, praluent 

Two large Phase III studies of Sanofi’s Praluent and Amgen’s Repatha have found the biologic cholesterol-lowering drugs are more effective in high-risk patients than statins.

In an ODYSSEY long-term study, 2,341 people who were already being treated for high cholesterol were treated with either Praluent (alirocumab) in addition to their usual treatment, or a placebo, for 78 weeks.

After 24 weeks the average reduction in LDL-cholesterol was 62% greater in the Praluent group than in the placebo group.

Cardiologists flagged up the higher rate of neurocognitive events, which occurred in about 1 in 100 people on Praluent compared with 1 in 200 people in the placebo group, as an issue that joint marketers Sanofi and Regeneron will need to address to convince regulators.

In Amgen’s OSLER-1 and OSLER-2 trials, some 4,465 people with high cholesterol were treated with either Repatha (evolocumab) plus statins, or statins alone. After one year of the average reduction in LDL-cholesterol level was 61% greater in the Repatha group than the statin group. Repatha maintained its efficacy over a two-year period and no new safety signals were identified.

Neurocognitive problems occurred more frequently in people who had treatment with Repatha, although the rate in both groups was low (fewer than 1 in 100 people), so may also be a worry for Amgen.

In both studies treatment with Praluent and Repatha – both fully human monoclonal antibodies – reduced the rate of cardiovascular events by about half. After one year the rate of cardiovascular events was lower in the Repatha group (1.0%) compared with the standard therapy group (2.2 per cent). And the rate of cardiovascular events was lower with Praluent, at 1.7%, than in the placebo group (3.3 per cent).

The studies were presented at a late-breaking session at the American College of Cardiology annual conference in San Diego, and published in the New England Journal of Medicine.

Sanofi and Amgen have filed applications for both drugs with the FDA. The US regulator has set a priority deadline of 24 July for its decision on Praluent, which many analysts predicting a rapid approval. The FDA is due to make a decision on Repatha on 27 August.

Professor Jennifer Robinson, director of the prevention intervention centre at the University of Iowa who led the ODYSSEY study, says: “These results demonstrated the durable efficacy for Praluent and further reinforce its generally consistent safety profile. Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent, and we look forward to results from the ongoing outcomes trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events.”

Dr Marc Sabatine, a senior doctor of cardiovascular medicine at Brigham and Women’s Hospital in Boston – and the Repatha study author – says the mechanism of this class of drugs makes physiological sense.

“The reduction in LDL was profound and that may be why we saw a marked reduction in cardiovascular events so quickly. It suggests that if we can drive a patient’s LDL cholesterol down a large amount to a very low level, we may start to see a benefit sooner than would be expected with a more modest intervention.”

Sabatine adds: “We won’t have any definitive answers until this larger trial we are doing is complete, but these data now give us a sense for the potential clinical benefit of these drugs.”

Lilian Anekwe

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