Swedish Orphan Biovitrum AB (publ): sirolimus

We also acknowledge receipt of your amendment dated May 29, 2026, which was not reviewed for this action.

Following a CGMP inspection and pre-license inspection 0 conveyed deficiencies to the representative of the facility.

FDA may determine that a CGMP reinspection and/or additional pre-license inspection (PLI) is needed to confirm satisfactory resolution of inspection deficiencies before this application can be approved.

The facility should provide satisfactory responses to these deficiencies to the FDA office that conducted the Remote Regulatory Assessment prior to your complete response to this letter.

Your complete response should include the date(s) of the facility's correspondence(s) to address these deficiencies.

FDA may need to perform an onsite PLI before this application may be approved.

Please be aware that we will not initiate the PLI until your complete response is received.

Add the following bolded statement or appropriate alternative to the carton and container labeling per 21 CFR 208.24(d): "ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide."

Consequently, the impact of CYP3A4 inhibitors on each form of sirolimus are not determined, and the clinical relevance of exposure matching for total sirolimus remains unclear.

8. We recommend conducting a hepatic impairment study to evaluate the impact of varying degrees of hepatic impairment on the pharmacokinetics (PK) of the ) | sirolimus component of your proposed product to inform appropriate dosage regimens for this special population.

9. The population PK analyses for both [I sirolimus and pegadricase require further refinement and optimization on the structural models and covariate identification to improve model robustness and reliability of model application.

06/26/2026 10:05:06 AM signing as a proxy on behalf of CG)