Regeneron's anti-cholesterol drug Praluent reduces death risk in trial

The anti-cholesterol drug Praluent (alirocumab), made by France's Sanofi Pharmaceuticals, is linked to a 15 percent lower risk of major cardiovascular events like heart attack and stroke, a study said Saturday. This action of the drug allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood.

The cost of PCSK9 inhibitors, which also include Amgen's Repatha, is more than $14,000 per year, according to the Institute for Clinical and Economic Review, which has raised concern about their availability to those who need them.

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.

Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite technologies, including VelocImmune to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world. "I hope this particular study really is a trigger for making this drug much more available to people who need it". "It is remarkable that such a potent intervention is also so safe", Dr. Philippe Gabriel Steg, chief of cardiology at Bichat Hospital in Paris and co-chairman of the study, said in an ACC press release.

The benefit was even greater among those with stubbornly high "bad", or LDL cholesterol, above 100 mg/dL.

The Odyssey Outcomes trial, which met its primary endpoint, was held in almost 19,000 patients who had a recent acute coronary syndrome (ACS) event, such as a heart attack. Some patients who switched to 150 mg switched back to 75 mg if their LDL-C fell below 25 mg/dL (n=805), and patients who experienced two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose (n=730) stopped active Praluent therapy for the remainder of the trial. Compared with FOURIER, the ODYSSEY Outcomes trial enrolled a higher-risk group of patients, had a longer duration of follow-up (ranging from two to five years), involved a different dosing strategy and had a slightly different primary endpoint. 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 past year worldwide, evolocumab $319 million.

A trial of the drug presented at the American College of Cardiology's annual scientific session showed it was more effective in preventing heart attack, stroke and all-cause mortality than a placebo, but physicians are still puzzled by access barriers to alirocumab and evolocumab, another PCSK9 inhibitor.

A first outcomes trial past year, called Fourier, similarly reported that Repatha, a different PCSK9 inhibitor called evolocumab, reduced the risk of death, heart attack, stroke, hospitalization for angina or revascularization procedures. It's the first study with a PCSK9 inhibitor to show an associated mortality benefit, researchers said.

The manufacturers were pleased with the results, suggesting there may be more people who can benefit from them - including with conversation about the high cost of the drugs. A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said.

(Copyright © 2015. All Rights Reserved.)
 
Recommended

U.S. notes Taliban 'interest' in peace talks
Mattis told reporters that he thinks victory is still possible - defined as a political settlement with the Taliban. United States Defence Secretary James Mattis made an unannounced visit to Afghan capital Kabul on Tuesday.

PA blames Hamas after explosion targets Palestinian PM entering Gaza
The top Palestinian Authority officials made the rare trip from the West Bank for the inauguration of a desalination plant. The World Bank, European Union and other European governments have paid almost $75 million in funding.

Sridevi's uncle reveals SHOCKING details about her married life with Boney Kapoor
Did they stand up on the wall and shout. " Sridevi sold her properties and cleared those debts to get life back on track". The same report states that the Tamil superstar was also willing to star in Boney's production.

Silva ruled out as Southampton's leading candidate named
It was widely believed that Silva would top Southampton's list of replacements for Mauricio Pellegrino , who was sacked by the club on Monday.

Castro trusts his team's ability to defeat Man United
Said midfielder Matic: "The next game is very important for us, maybe the most important game of the season". He came in for a big game and did the business, but I wouldn't be surprised if he's back on the bench.

NCAA women's hoops tournament: UConn could play in Albany
With most of their players back from last season's runner-up finish, the Bulldogs hope to make another deep NCAA run. OR is the 2-seed in Notre Dame's region, Ohio St is the 3-seed, Texas A&M the 4-seed and DePaul the 5-seed.

Mark Hamill is coming to Ireland for St Patrick's Day
The legend that is the one and only Mark Hamill is coming to Ireland to help us bring in our biggest national holiday . There's a roughly 30-year gap between the end of Return of the Jedi and The Force Awakens .

TDP renominates Ramesh for Rajya Sabha seat
In the Lok Sabha, members belonging to Congress, Trinamool Congress and others trooped into the well raising slogans. With members continuing their protest, the Chair was forced to adjourn the House till 2pm.

Rabada, De Villiers star in series-levelling win
Du Plessis expressed concern that the sport's authorities were being too sensitive in policing such matters. I said to him last night I'm just really pleased to see that he is walking the talk.

Case Keenum Intends to Sign With Broncos When Free Agency Opens Wednesday
He started 15 games for the Vikings in 2016, completing 71.6-percent of his passes for 3,877 yards and 20 touchdowns. That doesn't all go on the players. "I feel like we can get right back in the thick of the things rather quickly".

Cardinals offer family connection for Kirk Cousins
Cousins had mentioned in an interview that he would "love it" if the Denver Broncos are interested in him, which they are. This time, he has the opportunity to earn life-changing money few journeymen ever see.

Newly-released DoD video purportedly shows Navy pilot's encounter with UFO
It is time to set aside taboos regarding " UFOs " and instead listen to our pilots and radar operators. Unfortunately, we have no idea, because we aren't even seeking answers .

Nintendo Switch Version 5.0 Brings New User Icons and More
They are then free to send friend requests to their Facebook and Twitter friends who also use the Nintendo Switch . Here's all of the changes coming to the Switch with version 5.0 from the official Nintendo site .

Ivan Rakitic: 'I'd welcome Neymar return to Barcelona'
FC Barcelona playmaker Philippe Coutinho has commented on the rumours linking his global teammate and friend Neymar with a return to the Camp Nou.

Here are the real reasons Trump blocked Broadcom's Qualcomm takeover
Claiming that an acquisition of San Diego based Qualcomm by Broadcom is a national security risk, President Donald J. Buying Qualcomm would make Broadcom the third-largest chip maker, behind Intel Corp. and Samsung Electronics Co.


More News

News
More News