Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death
Regeneron And Sanofi Say Test Shows Praluent Lowers Risk Of Death
Sanofi and Regeneron presented Odyssey outcomes data for Praluent at ACC 2018 on Saturday
12 March, 2018, 22:38
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.
"With almost 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients", added Elias Zerhouni, president, Global R&D, Sanofi.
The drug reduced risk of MACE - a composite endpoint defined as heart attack, ischemic stroke, death from coronary heart disease, or unstable angina following hospitalisation - by 15%.
Long-awaited data from the 18,924 patient ODYSSEY OUTCOMES trial, announced at the American College of Cardiology's annual conference in Orlando, showed the study met its primary outcome.
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.
The companies will take a precision medicine approach, to address the burden of cardiovascular disease, focusing efforts on high-risk patients most vulnerable for future cardiovascular (CV) events, such as those who have suffered a previous coronary event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite maximally-tolerated statin therapy.
People who started the study with LDL cholesterol of 100mg/DL or higher had a 24-percent reduction in the risk of heart attack or stroke and a 29-percent lower risk of death.
Amgen also tried to have Repatha removed from the market in a patent infringement court case, which Sanofi fought off.
"We will begin working with payers to ensure that high-risk patients have appropriate access".
Both drugs were approved with a few weeks of each other in summer 2015, and have since been made available in patient-friendly monthly jabs, but neither have produced the blockbuster-level sales expected by investors.
As a result, Regeneron and Sanofi will offer payers that agree to reduce onerous access restrictions for high-risk patients an even further reduced net price for the drug.
Patients were randomized equally to be treated either by Praluent injection or a placebo, with the treatment period lasting an average of 2.8 years.
In terms of safety and tolerability, the only significant difference between the two study groups was minor local site reactions (mild itching, redness or swelling) at the injection site, which occurred in 3.1 percent of those receiving alirocumab and 2.1 percent of those receiving placebo. Approximately 90% of patients were on a high-intensity statin.
For those in the Praluent treatment arm, an estimated 75% of patient time was on the 75 mg dose. The analyses presented included the results from 730 patients (8%) in the Praluent group who continued to be assessed in the Praluent arm despite stopping therapy with the drug, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL.
Who were the perpetrators of the abuse? Vicky Round was hooked by the gang on heroin and crack and later died of substance abuse. In 2002 another schoolgirl - Becky Watson, 13 - was killed in an unexplained auto accident in the Shropshire town.
This includes Surface Hub , the large-screen video collaboration device for huddle spaces and other small-to-medium meeting rooms. The latest enhancements break down along the lines of features and functionality, calling, and device support , Wright said.
Both cases are now being looked at as being related, according to Manley, who says there are similarities of the two incidents. That case was originally being investigated as a suspicious death but has now been reclassified as a homicide investigation.
They had a wonderful opportunity in the 30th minute as Emiliano Alfaro picked out Marcelinho's run into the box on the left. Bengaluru's defence was impressive in the first leg, so it's highly unlikely that Roca would change the set-up.
She already has conducted an interview with contributor Anderson Cooper, although it is not known when the show will air. It also seeks to stop Trump and Cohen from trying to block her upcoming appearance on '60 Minutes'.
You will never look at hair gel the same way again after Cameron Diaz's run-in with Ben Stiller in There's Something About Mary . She said: "We are so different from one another, but we share the same values.We are both just weird enough for each other".
Neither Apple nor Texture is disclosing the exact amount of the deal, or what Apple plans to do with Next Issue Media's talent. And yet, CNN's Dylan Byers, who interviewed Cue, asked why the NRA has a presence in the App Store and on Apple TV.
Mahal made a surprise appearance at the end of the match only to be on the receiving end of the Glorious DDT from Roode. Roode has been champion since January 16th after defeating Jinder Mahal in tournament finals for the vacant title.
A convoy of relief trucks crossed front lines into eastern Ghouta on Friday and unloaded all its food despite the fighting. More than 1,000 people have been killed since the large-scale government offensive began on February 18.
In his video, Tyson answered questions posed by comedian Chuck Nice, who started it off by simply asking him if Earth is flat. At noon, when the sun is directly over your head, try looking at the bottom of the well.
In 2016, the United Nations passed a non binding resolution that internet access disruption is a human right ( The Verge ).
Air Canada experiencing nationwide system outage
The glitch led to long delays at YVR for passengers who either had to wait a long time or weren't able to board their flights. He said Air Canada contacted the airport at 10 a.m.to say the problem stemmed from an IT issue.
Jimmy Graham expected to sign with Saints or Packers?
Expect to hear more news come out in the near future about Graham and where the next chapter of his career will be played. The Packers need a veteran tight end after deciding to replace Jared Cook with Martellus Bennett last offseason.
Yankees agree to terms with 2B Walker
The Bombers agreed to a one-year deal with second baseman Neil Walker , the Daily News confirmed Monday morning. According to FanRag Sports' Jon Heyman, the deal is believed to be a one-year deal worth $5 million.
Rite Aid Corp (RAD) Check on Ratings
According to analysts Rite Aid Corp (NYSE:RAD)'s minimum EPS for the current quarter is at $-0.04 and can go high up to $0.01. Ross Margolies increased its stake in Citigroup Inc (C) by 6.68% based on its latest 2017Q3 regulatory filing with the SEC.
Time Warner Inc (NYSE:TWX) Holdings Reduced by Bank of Hawaii
The current share price indicates that stock is -6.58% away from its one year high and is moving 27.23% ahead of its 52-week low. Sentinel Trust Com Lba accumulated 1,978 shares. (NYSE:TWX) has "Hold" rating given on Thursday, April 20 by Pivotal Research.
Australia won't join USA steel WTO action
Japan said it would study the move's impact on Japanese companies before responding further. The tariff is collected by customs officials and goes to the government.
Former Bears and Cardinals TE Gedney passes away
He had 28 receptions in his first three seasons before landing on injured reserve prior to his fourth campaign. After his playing career, Gedney went into broadcasting as a football analyst for Cardinals games.
RWC Asset Management LLP Sells 4145 Shares of Pfizer Inc. (PFE)
It turned negative, as 35 investors sold FE shares while 155 reduced holdings. 165 funds opened positions while 367 raised stakes. In related news, insider Mikael Dolsten sold 13,986 shares of the business's stock in a transaction dated Friday, March 2nd.
Louisiana adds 1100 jobs over 12-month period through January
Learn more about how unemployment rates are calculated here: http://www.hoosierdata.in.gov/infographics/employment-status.asp . Meanwhile, professional and business services ticked upward by 6,200 jobs, and education and health services rose by 4,600.
Taro Daniel stuns Novak Djokovic at Indian Wells
That came after a breakthrough 2017 which saw him win four titles, including Sofia, Cincinnati, Brisbane and the ATP Finals . While the Spaniard converted all three of his break chances, he also saved seven of Dimitrov's 10 break points.