The development team from Sanofi and Regeneron journeyed to the ESC Congress in Barcelona this weekend to detail the impact their late-stage PCSK9 drug alirocumab has on bad cholesterol, drawing some high-profile attention for a batch of preliminary numbers suggesting a trend toward lower cardiovascular risks.
Amgen has taken another big step in its head-to-head race with Sanofi and Regeneron, filing its application for the prospective cholesterol blockbuster evolocumab and backing it up with more positive data from the latest in a long string of major clinical studies.
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.