Cholesterol drug lowers risk of death, heart attack

  • Cholesterol drug lowers risk of death, heart attack

Cholesterol drug lowers risk of death, heart attack

Praluent, or alirocumab, a relatively new cholesterol drug, is effective at lowering heart attack and death risk, according to a study sponsored by manufactuers Sanofi and Regeneron Pharmaceuticals.

Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to USA payers that agree to reduce "burdensome access barriers" for high-risk patients.

Praluent and a similar drug, Amgen's Repatha, work in a different way and lower cholesterol much more.

The worldwide trial, involving 18,924 patients, is the first to show the new class of drugs has the ability to extend lives and could work better than statins, which are cheap and commonly prescribed, but remain mired in controversy. Despite their striking ability to lower gobs of LDL-C or "bad" cholesterol, their sales have been meager compared to Wall Street analysts' initial bullish multi-billion dollar projections; alirocumab tallied $194 million a year ago worldwide, evolocumab $319 million.

"We will begin working with payers to ensure that high-risk patients have appropriate access".

Problems with patient access have been documented in numerous studies. Months can go by before a patient gets them.

Dr. Valentin Fuster, who critiqued the trial at the meeting but was not involved in the study, said the data show that what is considered normal LDL today may be too high. The study is the second of its kind-following a similar, 27,564-patient trial from Amgen previous year.

The new NHS therapy is given to those whose cholesterol remains dangerously high despite taking the maximum dose of statins, or who can not tolerate the drugs. Both studies have been seen as critical to proving PCSK9 blockers are worth their high price tags. Regeneron and Amgen have been hoping to make PCSK9 blockers available to more and more of the millions of patients who can't reduce their risky cholesterol levels with statins, or can't tolerate them because of side effects. After almost three years, 9.5 per cent of those on Praluent and 11.1 per cent of those on dummy medicine had suffered a heart attack, stroke, heart-related death or serious chest pain; 3.5 per cent on Praluent and 4.1 per cent on dummy medicine died.

Regeneron and Sanofi shared the new data with ICER in advance of the Saturday presentation.

"This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline", said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron.

The makers of an expensive cholesterol-lowering drug plan to offer discounts of up to 69% in exchange for insurers and pharmacy-benefit managers expanding their coverage of the medicine to more patients. The discount deal would apply only to patients with dangerously high levels of cholesterol who are at especially high risk for heart attack or stroke.

Ben Fidler is Xconomy's Deputy Biotechnology Editor.