An FDA advisory committee will consider modifications to the indicated patient population, as well as the appropriate health professionals and settings to administer the proposed treatment for radicular leg pain.
The FDA may narrow the patient population and limit treatment sites for Seikagaku's leg pain drug. (Shutterstock)
Key Takeaways
FDA advisors will vote on the benefit-risk balance of Seikagaku's condoliase injection for treatment of radicular leg pain on 10 January.
Seikagaku Corporation may need a narrower indication and a Risk Evaluation and Mitigation Strategy limiting the providers and...