Home / Health / FDA Rejects Grace Therapeutics Stroke Drug
FDA Rejects Grace Therapeutics Stroke Drug
23 Apr
Summary
- FDA declined approval for Grace Therapeutics' stroke drug.
- Deficiencies cited in chemistry, manufacturing, and data.
- Company states issues can be addressed in resubmission.
Grace Therapeutics received a complete response letter from the U.S. Food and Drug Administration on Thursday, indicating a decline in approval for its drug aimed at treating a rare type of stroke. The regulatory agency identified specific deficiencies in the chemistry, manufacturing, and controls (CMC) sections of the company's application. Furthermore, issues were noted concerning the non-clinical data submitted.
The FDA's concerns included problems with leachables data related to product packaging, assessments of non-clinical product toxicology risks, and manufacturing deficiencies identified at a contract manufacturing organization. Grace Therapeutics has indicated that it believes these issues are addressable and intends to resubmit its application to the FDA.
