Sanofi and Regeneron just stole a march on Amgen in the race to get their PCSK9 cardio drug through the FDA and onto the market. The two companies revealed Wednesday evening that they had picked up a priority review voucher BioMarin had won for a recent rare disease drug approval, paying $67.5 million for the regulatory shortcut. They'll split the cost and share in the benefit, shaving four months off the regulatory review time for alirocumab.
Sanofi and Regeneron are heading to the FDA with a potential blockbuster cardiovascular treatment, touting positive results from a slew of Phase III trials in which the drug slashed patients' bad cholesterol.
Amgen's in-development cardio drug came through in two more late-stage trials, significantly lowering bad cholesterol in patients with genetic disorders that put them at serious risk.
Pharmacy benefits managers say they're just as worried--perhaps even more so--by a coming class of cholesterol drugs known as PCSK9 inhibitors as they are about the new crop of hepatitis C treatments.
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.