The blood-thinner Xarelto has added some upbeat Phase III data to its resume. Bayer ($BAYN), which is co-developing the drug with Johnson & Johnson ($JNJ), said the drug met its primary efficacy endpoint in sufferers of acute coronary syndrome. Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) failed last year to hit the mark with a similar experimental drug, apixaban (Eliquis), in a trial involving ACS patients.
Patients on Bayer and J&J's clot-buster showed a drop in the rate of events--such as cardiovascular death, heart attacks and strokes--compared with those receiving a placebo, Bloomberg reported. The Atlas trial involved patients who took Xarelto and standard therapy and others on standard therapy and a placebo. With the data, the developers are gearing up to submit applications before the end of the year for approval in the ACS group.
While the data are a "surprise win" for the companies, there are some lingering concerns about the increased risk of bleeding from the therapy and questions about what the optimal dose should be, Leerink Swann analyst Seamus Fernandez said in a note to investors. Bayer plans to present data from the Atlas study at a future medical meeting. Fernandez added: "...the devil will clearly be in the details when presented."
The key market for the drug remains atrial fibrillation. An expert panel backed approval for Xarelto in preventing strokes in the Afib group earlier this month, setting the stage for a potential FDA approval in this indication in early November. A market green light from U.S. regulators would likely beef up the drug's potential to reach blockbuster status, according to analysts. The drug was previously given a market green light for the largely niche use of preventing clots in patients who undergo certain surgeries.
- check out the Bloomberg article
- see the RTT News report