Some of the leaders in the frenzied late-stage race to develop a PCSK9 drug watched their stock prices stumble on Friday afternoon as word of the FDA's concern about potential neurocognitive side effects in the cholesterol drug class ripped through Twitter.
Amgen is batting 1.000 in its ambitious clinical program for the promising PCSK9 cholesterol drug evolocumab (AMG-145), unveiling a 5th successful Phase III study as it prepares for an FDA application that could give it first-mover status in a blockbuster field.
Amgen marched through yet another Phase III study for the closely watched PCSK9 cholesterol drug evolocumab (AMG-145), racking up more promising data for one of the biggest late-stage programs in the business.
Amgen's promising PCSK9 candidate cleared another Phase III hurdle, this time in statin-intolerant patients, as the company piles up positive data with hopes of taking the lion's share of what could be a multibillion-dollar market.
Amgen's PCSK9-blocking evolocumab hit its primary endpoints in a Phase III study, the company said, bringing down bad cholesterol and stirring fresh hope for the company as it races with Pfizer, Sanofi and others to cash in with a new approach to cardiovascular treatment.
On the heels of new guidelines casting doubts on a much-hyped new class of cholesterol drugs, the FDA said it would not demand long and costly outcomes trials before approving PCSK9 treatments from the likes of Amgen, Sanofi and Regeneron, clearing the way for treatments expected to rake in up to $3 billion a year.
Tantalized by various megablockbuster projections for the PCSK9 field of cholesterol drugs, Pfizer has mapped out one of the most ambitious late-stage programs in the industry for RN-316.
Sanofi and Regeneron have rolled out promising Phase III data on their cholesterol drug alirocumab, which handily breezed by Merck's Zetia in lowering bad LDL cholesterol. The partners are in a high-stakes race to win the first regulatory approval for a PCSK9 inhibitor.
In an industry like pharma, you're only as good as your next big Phase III study. And hopes are running very, very high for the first round of late-stage results on the PCSK9 drug alirocumab from Sanofi and Regeneron.
After partners Regeneron and Sanofi announced more than 10 late-stage studies last year, Regeneron revealed plans Tuesday to take a shot at a trial to test less frequent dosing of the experimental therapy.