Eye blockbuster Eylea has been churning out serious revenue growth for Regeneron since it hit the market, and now the company is inching closer to approval for its much-watched PCSK9 therapy. But what comes after that for the New York biotech? Analysts disagree.
After last week's expert panel meetings, the FDA may put some label limits on PCSK9 cholesterol drugs. But Sanofi, Regeneron and Amgen can take heart.
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.
U.S. payers are striking out at drug spending again, highlighting the cost to taxpayers. According to a commissioned report, 10 hot new "breakthrough" meds are expected to cost publicly funded healthcare plans more than $50 billion over the next decade.
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.
Regeneron has advanced dupilumab, regarded by many as the company's next big innovation, into a Phase III asthma study, rolling toward an FDA submission behind its lead eczema program.