FDA warning for blockbuster hopeful edoxaban hits Daiichi where it hurts
- After a period of longstanding success, Japanese drug maker. Daiichi Sankyo is facing patent expiry on its top-selling drug, Benicar (olmesartan) used to treat hypertension, as well as a long list of other challenges, including an FDA-imposed black box warning on its promising new blood thinner, edoxaban.
- Daiichi Sankyo forecasted a 6.7% increase in profits to roughly $554 million for the fiscal year that ends in March.
- In Japan, Daiichi has cut 6% of its employees—a total of 513 jobs. It also plans to shrink inventory over the next two years to gain additional cost-savings.
Benicar has been a strong-selling drug in Daiichi's portfolio, representing 27% of revenues. With patent expiration just a year away, Daiichi has been looking towards new drugs, including edoxban to make up for lost revenues. But the FDA's black box warning could dampen those goals.
The black box warning is a really huge concern, because it warns that patients with normal renal function (NOT abnormal function) could face decreased efficacy with edoxaban. Not a good thing. Overall, the class of new oral anticoagulants (NOAC), of which edoxaban is part, offers an easier-to-use anticoagulation option for patients with atrial fibrillation. However, edoxaban is the fourth drug to market in this category.
Despite these factors, Daiichi is forging ahead, considering acquisitions and selling Ranbaxy.