Thanks to genomic sequencing, some heart-healthy mutants and billions of dollars spent on R&D, rival drug developers are bearing down on a promising new way of treating the scourge of high cholesterol. And with the first FDA applications likely coming in the next year, the nascent field's trailblazers are vying for the top spot with blockbuster aspirations.
Amgen widened its lead among competing drugmakers in a promising new field of cardio treatments on the strength of late-stage results in which its in-development drug lowered LDL cholesterol by as much as 75%.
Pfizer says the Phase IIb study for its closely-watched PCSK9 cholesterol drug bococizumab (RN316) scored the primary endpoint on all doses, which should help steer a massive Phase III program that started out last fall with 22,000 patients.
Amgen's promising cardio drug aced its 6th late-stage study, the company said, beating out statins in patients with a cholesterol-boosting genetic disorder and widening the drugmaker's lead in a potentially lucrative new field.
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.