Johnson & Johnson 'knew about asbestos in baby powder for decades'
Unconstitutional: Federal Judge Strikes Down Obamacare
Government report reveals which drugs are most frequently used in overdose deaths
J&J shares nosedive on report it knew of asbestos in Baby Powder
Cholesterol drug lowers risk of death, heart attack
14 March 2018, 12:57 | Randall Craig
Regeneron and Sanofi Plan to Cut Cholesterol Drug Price in Exchange for Wider Coverage
Regeneron and Sanofi's move to adopt ICER's recommended price range reflects the growing scrutiny of drug costs, and calls for pharmaceutical companies to price their products according to their value to patients, rather than what the market will bear, ICER President Steven D. Pearson said in an interview. "We are prepared to change this by improving access and affordability, eliminating these burdensome barriers for high-risk patients in need".
In the large Odyssey study, Praluent statistically significantly reduced the risk of MACE (the primary endpoint based on a composite of heart attack, ischemic stroke, death from coronary heart disease, or unstable angina requiring hospitalization) by 15% (similar to the benefit seen from Amgen's Repatha in a different outcomes study of slightly less sick patients) with a strong p-value of 0.0003.
Regeneron's (NASDAQ: REGN) alirocumab and Amgen's (NASDAQ: AMGN) evolocumab (Repatha), both approved in 2015, belong to a new class of cholesterol lowering medicines called PCSK9 inhibitors, which has been a key battleground between payers and drugmakers.
The PCSK9 inhibitor, which lowered blood lipids by 40-60% in previous trails, reduced the risk of MACE by 15% and was associated with a 29% lower risk of death overall in a patient population with acute coronary syndrome. They had LDL cholesterol at 70 mg/dL or above and non-HDL cholesterol 100 mg/dL or above. An Amgen-backed study released yesterday, for instance, found 65 percent of commercially insured and Medicare patients trying to get a PCSK9 blocker were denied access by their health plans in 2016. A price of $4,500 to $8,000 per year would be justified for patients at higher risk, with LDL over 100. Cardiologists interviewed by Xconomy say the drugs are nearly always rejected upon first request.
Investigators followed the patients for an average of 33 months.
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. "It's so hard, I give up".
The offer has been made just after the presentation of the large-scale ODYSSEY OUTCOMES at the American College of Cardiology (ACC) meeting in Orlando, which showed that adding PCSK9 inhibitor Praluent (alirocumab) to high-dose statins reduced cardiovascular events and all-cause mortality compared to statins alone. 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 unsafe cholesterol levels with statins, or can't tolerate them because of side effects.
On Saturday, the independent group said Praluent should cost, based on the new results, between $2,300 to $3,400 per year for people like those in the study.
The companies and the researchers who oversaw the trial focused on one subset of the patients, accounting for about 30% of the group, whose bad "LDL" cholesterol levels remained stubbornly high despite aggressive treatment to lower it.
Armed with that data, as well as new cost-effectiveness analysis from the US Institute for Clinical and Economic Review (ICER) which provide new estimates of the price range that would be acceptable for the drug - depending on the patient's level of risk.
Ben Fidler is Xconomy's Deputy Biotechnology Editor.
Taylor Swift Returns to Her Roots, Casts Gay Porn Star
But a source close to Swift defended the singer, saying her video has a "beginning, a middle and an end", plus multiple locations. In the video and the ad, Swift and Qualley both make silly faces and dance awkwardly throughout a fancy venue wearing gowns.
Bears to sign Super Bowl hero Trey Burton
He posted 37 catches for 327 yards and one touchdown in 2016 and 23 receptions for 248 yards and five scores in 2017. That's some serious money for a player who was the No. 2 tight end for the Philadelphia Eagles last season.
Case Keenum to sign with Broncos
According to Nicki Jhabvala, by way of the mean streets of Twitter, Denver had its eye on signing Case Keenum all along. It also speaks to just how impressed they apparently were with Keenum that they pulled the trigger on a deal so quickly.
Short hair changes Katy Perry's view on make-up
Richie was especially impressed by the high notes. " Trevor , he's hot, he does construction on the side, and he loves his mom". He accompanied himself on the guitar, and the judges were smitten-especially Perry, who flirted back a bit.
Sam Bradford intends to sign with Arizona Cardinals
The Cardinals have been looking for a replacement at quarterback following the retirement of Carson Palmer after the 2017 season. Sam Bradford appears set to land on his feet during this dizzying period of National Football League free agency.