It's no surprise that Sanofi and Regeneron won FDA approval for Praluent, the PCSK9 cholesterol-fighter. But the drug's list price is another matter. At $14,600, it's almost 50% more than many analysts had estimated.
Amgen may be running a beat or two behind Regeneron and Sanofi in search of the first FDA approval for a PCSK9 drug, but the Big Biotech scooped up the very first approval in Europe today for Repatha (evolocumab), giving the company boasting rights as first mover in what is widely seen as a new blockbuster market in the making.
The year's 10 highest-paid development executives pulled in $124.4 million in total compensation, a roughly 35% jump over 2013's top earners. And while each entrant benefited from meeting individual company goals, the whole group benefited from biopharma's macroeconomic moment in the sun, as the value of stock awards skyrocketed alongside the industry index.
You can't accuse Sanofi and Regeneron of slacking. Partners on the forthcoming cholesterol fighter, Praluent, the drugmakers have been laying an awareness foundation for months. A cholesterol-testing campaign, a patient-awareness poll, advocacy partnerships--and now, a documentary.
After last week's expert panel meetings, the FDA may put some label limits on PCSK9 cholesterol drugs. But if word from doctor surveys is any indication, those limits won't put a huge damper on sales.
A cholesterol-slashing treatment from Sanofi and Regeneron won over a key FDA panel, signaling a likely approval but leaving unclear just which patients should get the new medicine, believed to be a blockbuster in the making.
The blockbuster race between Amgen and a team from Regeneron and Sanofi for cutting-edge PCSK9 drugs comes down to this: back-to-back panel reviews to discuss the designated endpoint for cutting LDL as a surrogate for cardio benefits as well as the potential negative effect these new drugs could have on the massive demand for statins.
A potential blockbuster from Sanofi and Regeneron has proven its ability to slash rates of cholesterol, the FDA said, but questions remain on just how widely the treatment should be used.
Payers have promised a fight over the price of PCSK9 drugs, a new class of cholesterol fighters. Drugmakers in the field--including frontrunners Amgen and Sanofi--prepared for that fight. And now, analysts think they've defined the battle lines.
Regeneron posted another round of clinical successes from its sweeping Phase III rheumatoid arthritis program, plotting to submit its Sanofi-partnered antibody for regulatory scrutiny this year.