Certain patients in the UK struggling to keep their cholesterol levels in check now have the option of treatment with Sanofi’s PCSK9 inhibitor Praluent following its launch across the country.
The move follows the drug’s authorisation in Europe for the treatment of patients unable to reach their low-density lipoprotein (LDL), or ‘bad’ cholesterol treatment goals, despite a healthy diet and taking a maximum tolerated dose of a statin and/or other lipid-lowering therapies.
Patients now eligible for treatment include those with high levels of LDL cholesterol, heterozygous familial hypercholesterolaemia, and those who can’t take statins.
High cholesterol levels are a major risk factor for cardiovascular disease, which accounts for a quarter of all deaths in the UK every year, equating to around one person dying every three minutes from the condition. Just 24% of high risk patients achieve optimal LDL cholesterol goals of <70mg/dl, highlighting the urgent need for new treatments and approaches.
And while cardiovascular disease death rates have fallen, healthcare costs to the NHS in England have risen from £6.9 billion to £7.9 billion between 2003 and 2010 due to an increase in the costs associated with managing these conditions, Sanofi notes.
The availability of Praluent (alirocumab) in the UK offers high risk patients “a new option to reduce their cholesterol levels with the aim of reducing their risk of heart attack and stroke,” said Adie Viljoen, UK Chief Investigator of three clinical studies involving the drug and consultant chemical pathologist at Lister Hospital, Hertfordshire.
Praluent become the second in the closely-watched PCSK9 inhibitor class of drugs to be cleared for the EU market last month, following in the footsteps of Amgen’s Repatha (evolocumab). It’s application was supported by data from 10 Phase III clinical studies which all met their primary endpoints.
In the placebo-controlled trials, the average LDL-cholesterol reductions from baseline at week 24 for the Praluent group ranged from 46% to 61%. In the ezetimibe (Merck & Co’s Zetia)-controlled trial with Praluent added to background statins, the average drop was 51% at week 24, while in ezetimibe trials with patients not on statins, the average reduction was 45%-47%.