- Bristol Myers Squibb and Johnson & Johnson have begun a series of large studies testing a closely watched experimental blood-thinning medicine, setting plans to include almost 50,000 patients.
- The Librexia trials, as they’re known, will be split into three parts to study the effects of milvexian in patients who have suffered from a stroke, acute coronary syndrome or atrial fibrillation. Researchers have already enrolled the first patient in the stroke trial and expect to start the other two by July.
- Milvexian is part of a new group of medicines called Factor XIa inhibitors that are designed to compete with existing blockbuster medicines such as Eliquis and Xarelto while offering better safety. Bristol Myers said Thursday its testing plans will offer the “most comprehensive and unrivaled” data set in the drug’s class.
The scope of the Librexia program exceeds even most vaccine studies, generally the largest trials in pharmaceutical development. And it outpaces plans by Bayer, which last month announced it would study its rival treatment, known as asundexian, in 27,000 patients.
The companies believe they have potential top sellers on their hands, with each predicting that revenue could top $5 billion. Eliquis, developed by Bristol Myers and Pfizer, brought in almost $12 billion last year. Bayer and J&J, which sell Xarelto in different markets, reported combined revenue of more than $7 billion for their product in 2022.
The promise of the new class of drugs depends on whether they can prevent strokes and other cardiac events as well as existing treatments while also lowering the risk of internal bleeding. Bristol Myers and Bayer both pushed into Phase 3 trials despite mixed results in earlier testing.
The companies are also racing against the clock. Eliquis and Xarelto will lose patent protection this decade, meaning cheaper generic versions will become available. If the companies can’t prove a significant safety benefit for their new class of medicines, doctors may see little reason to prescribe the drugs even if they do win regulatory approval.