Summary
- Johnson & Johnson received FDA approval for its drug Xarelto to treat blood clot patients with acute illness who are either hospitalized or discharged from the hospital.
- Xarelto has been approved by regulators for as many as 8 indications.
- Sales of Xarelto have struggled based on a competing drug Eliquis and gap coverage for Medicare. Despite some headwinds, Q3 2019 sales for Xarelto were $613 million.
- One advantage Xarelto can hang its hat on would be that it can be given as an oral drug once daily. Additional indications being approved should increase sales of the drug going forward.
- I do much more than just articles at Biotech Analysis Central: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »
Johnson & Johnson (JNJ) and its partner Bayer AG (OTCPK:BAYRY) announced that it received FDA approval for another indication for one of its blood clot drugs known as Xarelto. Specifically, this was approved for blood clots that can possibly occur in patients with acute illness who are either hospitalized or discharged from the hospital. This latest FDA approval becomes another one of many indications for Xarelto. Sales from Xarelto continue to grow and it is good to see that patients have alternatives other than standard of care drugs.
FDA Approval Provides An Oral Treatment Option
Xarelto was approved by the FDA to prevent venous thromboembolism (VTE) or VTE related death during hospitalization and post-hospital discharge in acutely ill medical patients. Specifically, these are patients who are not at high risk of bleeding but have a high propensity for a blood clot occurring. This FDA approval is good news for two reasons. One reason is that Xarelto can be given for these patients while they are hospitalized and then can continue to take treatment once they are discharged. Especially, since this drug can be taken orally. The total amount of time the patient can take it is in a recommended time frame of 31 to 39 days. The second reason why this FDA approval is good news, especially for patients, is because it provides a solid alternative to current standard of care. Current standard of care for VTE or blood clots for those with acute illness would be injectable anticoagulants. Looking closely into Xarelto, it is a good choice for treatment of VTE and even possibly other blood clot indications. For instance, Xarelto doesn't require constant blood tests like other anticoagulants. What may be needed from time to time would be a kidney test to make sure that everything is alright, but no need for constant blood tests. A downside is that Xarelto leaves the body quickly, which means that a patient must remember to take the drug every day. The good news is that Xarelto offers other advantages like less food/drug interactions and is less likely to cause severe bleeding like other anticoagulants like warfarin.
