WASHINGTON (Reuters) – Amgen’s Repatha drug cut the risk of heart attacks and strokes by over 20 percent in patients with heart disease, demonstrating a transparent clinical advantage over its ability to condense “bad” LDL cholesterol levels, information from a outrageous study famous as Fourier showed on Friday.
Results from the rarely expected 27,564-patient Fourier study should help mislay some barriers to studious entrance from health insurers and pharmacy advantage managers, who have been rejecting some 75 percent of prescriptions created for the dear medicine.
Repatha cut the total risk of heart attacks, strokes and heart-related death by 20 percent compared with a remedy in patients already on high doses of cholesterol-lowering statins, such at Lipitor. Most hearing subjects had had a before heart attack or stroke.
However, there was no disproportion in cardiovascular death in the two groups, which disappointed investors. Amgen’s batch was down as much as 6% Friday morning. Other cholesterol-lowering biotechs with drugs in development, Esperion and The Medicines Company were down 25% and 18%, respectively.
Separately, Repatha cut heart attacks by 27 percent and stroke by 21 percent. In the second year of the study, the results were some-more pronounced, with a 35 percent rebate in heart attack risk and a 24 percent diminution in stroke risk.
“Just like in statin trials the advantage seemed to grow over time,” pronounced Dr. Marc Sabatine, the study’s lead researcher, who presented the information at the American College of Cardiology systematic assembly in Washington.
“As a clinician this is very big news. We have another apparatus to significantly revoke heart attacks and stokes. That’s a big win,” pronounced Sabatine from Brigham and Women’s Hospital in Boston.
Longer term, Sabatine said, there could be a rebate in deaths as well.
The trial’s primary combination idea enclosed need for artery clearing procedures and hospitalization due to chest heedfulness from angina in further to heart attack, stroke and death. On that measure, the altogether risk rebate was 15 percent, essentially due to no disproportion from remedy in angina hospitalizations.
Repatha, injected possibly once or twice a month, lowered LDL by about 60 percent to a median of 30, with a entertain of patients getting next 20, researchers reported. Earlier discipline set an LDL aim of 70 for such high risk patients.
There were no reports concerning reserve issues. Incidence of cognitive decline, cataracts, new conflict diabetes and muscle-related side effects were identical to the remedy group.
The results should disencumber the purse strings of insurers demure to compensate for a drug with a list cost of over $14,000 a year before discounts, given the high cost of treating strokes and heart attacks.
“To see a some-more than 20 percent risk rebate for stroke was really exciting,” pronounced Amgen investigate arch Sean Harper.
Amgen pronounced it is holding stairs to mislay toilsome barriers to studious access, including a devise under which it would offer to reinstate Repatha costs for all authorised patients who have a heart attack or stroke.
Repatha and rival Praluent, from Regeneron Pharmaceuticals and Sanofi, work by restraint the PCSK9 protein that prevents LDL being private from the blood.
“The category is likely to grow to at slightest a $3 billion to $5 billion worldwide marketplace over the next 5 and years,” foresee RBC Capital Markets researcher Michael Yee.
Due to the high rejecting rate, sales have been malnutritioned – just $58 million for Repatha and $41 million for Praluent in the fourth quarter.
Sabatine pronounced he would like to see Repatha tested in other high risk patients, such as those with form 2 diabetes but before story of heart attack, which could almost boost the market.
“As a multitude we need to pierce to modifying these risk factors progressing in life to not only forestall memorable events but to forestall first events,” he said.
Reuters stating by Bill Berkrot.