New type of cholesterol drug worked in big study
FDA takes steps to boost generic competition, limit prices
TRENTON, NJ, June 28, (AP): Merck & Co said Tuesday that a new type of cholesterol drug reduced heart attacks, deaths and other complications of heart disease in a huge, late-stage study.
The positive result was a welcome surprise because three previous experimental drugs of the same type had failed.
Merck’s pill, anacetrapib, might eventually give high-risk heart patients a new option to add to cholesterol treatments that have helped prevent millions of heart attacks, strokes and deaths from heart disease. Cheap generics don’t cut those risks enough for many people, while two new cholesterol drugs cost $14,000 a year or more, so insurers have been restricting coverage.
The Merck drug works by blocking a protein called CETP. That’s a different way to control cholesterol than that of widely used, now-generic statins such as Lipitor and Crestor, and the newer injected drugs, Repatha and Praluent.
Anacetrapib was thought to benefit patients mainly by increasing HDL, or “good” cholesterol. Over time, Merck found it also significantly lowered “bad” cholesterol, or LDL, increasing the drug’s ability to prevent arteryclogging buildups of fatty plaques that can trigger heart attacks and strokes.
The company-funded study included 30,000 people, who were followed for more than four years. Half got the drug and the rest got dummy pills. Both groups also took atorvastatin pills, or generic Lipitor.
The size and duration of the study increased the chances that it would produce a positive result. Still, that might be just a modest improvement, Evercore ISI analyst Umer Raffat wrote to investors Tuesday.
Kenilworth, New Jersey-based Merck said it won’t release detailed study results until Aug 29, at a European conference of heart specialists. That’s standard practice, but Merck raised questions about how well the medicine works by noting the company will consult with outside experts before deciding whether to seek regulatory approval to sell the drug.
Normally, when testing shows a drug is effective and fairly safe, drugmakers rush to apply for approval.
Merck’s apparent success with anacetrapib comes after three major rivals — Pfizer Inc, Eli Lilly and Co, and Roche Group — each saw drugs of the same type fail because of lack of effectiveness or dangerous side effects. Roche Group is starting a new test in heart patients with a particular genetic variation, Raffat noted.
In its brief statement, Merck said its initial analysis of study data found side effects were about the same as in earlier, smaller studies, with the most significant issue being that anacetrapib can accumulate and remain in fatty tissue long after taking the drug. It’s un-
clear whether that is harmful.
The Food and Drug Administration said it’s taking steps to boost the number of generic prescription drugs on the market in an effort to make medicines more affordable and to prevent price gouging.
Copycat pills generally have been much cheaper than original brandname drugs. But recent high-profile cases have shown how lack of competition and medicine shortages allowed several drug companies to drastically increase prices for generics and some older brand-name products such as
EpiPen emergency allergy injectors.
New FDA commissioner Dr Scott Gottlieb made addressing prices a priority, saying that agency can help by increasing market competition. While the FDA reviews and approves medications, it doesn’t have the power to regulate prices.