Astellas Pharma (Astellas) reported that FDA has substantially denied its Citizen Petition to ensure the safe and effective use of immunosuppressants, used to prevent rejection in organ transplant patients.
Reportedly, in their petition, Astellas requested that FDA take additional measures to protect transplant recipients from substitute critical dose immunosuppressant drugs, that have not demonstrated bioequivalence in rigorous clinical trials in transplant patients.
In response, Astellas plans to file a complaint for declaratory and injunctive relief in US District Court in Washington, challenging FDA’s decision to apply standard bioequivalence testing for the approval of generic immunosuppressant drugs, like tacrolimus.
Under the FDA’s decision, bioequivalence testing is required only in healthy volunteers, not the patient population that will be treated with the new product.
Additionally, FDA denied Astellas’ request for labeling changes that require physicians to be notified whenever a substituted oral formulation is about to be provided to a transplant patient, so that the physician can determine whether additional drug blood concentration testing should be done to ensure the health and safety of the patient. Astellas is also challenging this part of the FDA’s decision.
William Fitzsimmons, senior vice president, US Development, Astellas, said: Astellas is firmly committed to the appropriate care and treatment of transplant patients. Transplant physicians are the most qualified to make decisions about their patient’s treatment and should be informed when the patient’s medication is switched from one formulation to another.
This is a specialized category of medicine and transplant patients are vulnerable to small differences in drug concentrations, which can lead to significant differences in their treatment outcome. We look forward to open discussion about this important issue, he added.