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NHS looks to ESC for next-gen heart drug data

Published on 28/08/15 at 08:36am
ESC congress sign
Pharma companies will present data on several new heart drugs at the ESC 2015 congress

New data is expected to be presented at the European Cardiology Society congress in London, on the high cholesterol drugs that are set to battle for market access in the UK.

Amgen’s Repatha (evolocumab) was the first in this new class of drugs - called PCSK9 inhibitors - to be approved, when it was signed off by the European Commission in July and has been approved by the FDA today. Its direct competitor, Sanofi and Regeneron’s jointly marketed drug Praluent (alirocumab), has already been approved by the EMA in Europe and the FDA in the US. 

Amgen will present six abstracts at the congress, including three evaluating Repatha, on the treatment’s long-term safety and efficacy in patients with statin intolerance, and a pooled analysis of three Phase III trials.

Dr Sean Harper, executive vice president of R&D at Amgen, says: "This has been a historic year for Amgen's cardiovascular franchise with multiple regulatory milestones, including the recent EU approval of Repatha, the first PCSK9 inhibitor approved by a regulatory agency in the world, and we're excited to continue the momentum with new data being presented at this year's ESC Congress.

"We are committed to continuing to evaluate Repatha and look forward to sharing long-term safety and efficacy data in patients who are unable to tolerate effective doses of statins, as well as findings on consistent LDL-C reductions in different patient subgroups."

Sanofi and Regeneron will also be showcasing data from the ODYSSEY trials of Praluent, including new data from a 78-week study of Praluent in patients with an inherited form of high cholesterol, called familial hypercholesterolaemia (FH).

The results are eagerly anticipated by NHS clinicians and advisors. Professor Huon Gray, who is national clinical director for cardiac care at NHS England – and a consultant cardiologist at University Hospital of Southampton – told Pharmafocus the data on the PCSK9 inhibitors could be significant for UK patient access.

“The data on the new high cholesterol drugs are very exciting. They have been approved by the FDA and there’s lots of interest and anticipation about their potential use in the UK. There will be interest in the data because all the indications so far are that they create quite a significant reduction in LDL-cholesterol levels.

“We have to see of course if that translates into reductions in cardiovascular events and outcomes that are comparable with statins. It sounds like something that we would be able to assume but of course we can’t. We have to have the data to prove that and I’m looking forward to seeing what data is presented and how that applies to patients in the NHS.”

Meanwhile other companies already have the recently-approved PCSK9 inhibitors in their sights and are a challenge to their market share.

At the ESC congress, The Medicines Company and Alnylam Pharmaceuticals will present Phase I data on a new drug the companies say will be a game changer in heart disease. The Phase I results will look at a newer class of drug – called ALN-PCSsc, which are based on RNAi technology. 

Like Praluent and Repatha ALN-PCS therapies are PCSK9 inhibitors, but with a different mode of action. Heart disease risk comes from genes which send instructions to the body to create proteins which, when linked with LDL-cholesterol, raise the risk of heart attack and stroke. Both Praluent and Repatha are monoclonal antibodies that act after the instruction has been sent.  ALN-PCScs work before the event, by silencing the gene so no instruction can be sent.

The ESC study will look at whether these drugs show a well-tolerated safety profile and similar levels of efficacy as the new generation of monoclonal antibodies. They are expected to show if they could be used as a twice-yearly injection, rather than an injection every two to four weeks in the case of the Sanofi  and Amgen drugs –potentially significantly affecting their cost.

Lilian Anekwe

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