5 vials of each batch for testing by the TGA Laboratories Branch together with any necessary standards, impurities and active pharmaceutical ingredients (with their Certificates of Analysis) required for method development and validation. Samples and data should be forwarded to the Laboratories Branch, Biochemistry Section, before release of each batch and with sufficient lead time to allow for testing. Note: This release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation. Secondary evaluations as per the evaluator: Sufficient evidence has been provided to demonstrate that the risks related to the presence of adventitious agents in the manufacturing of Teduglutide (Revestive) have been controlled to an acceptable level. There are no further objections from a microbiological viewpoint to the approval of the application to register Teduglutide (Revestive) 5 mg Powder for Solution for Injection Vial with Diluent Pre-filled Syringe. Nonclinical There are no nonclinical objections to the registration of teduglutide. The nonclinical evaluator noted the inclusion of the recommended PI amendments in the revised PI submitted with the Section 31 response. The Sponsor has proposed an ECP specification of 75 ppm, and the mean batch level of ECP (16 ppm) exceeds the ARGPM Guidance 18 threshold of 10 ppm. Accordingly, clinical advice is sought regarding the suitability of these proposed levels of ECP in terms of clinical safety and registration. Clinical advice: The Delegate accepts the microbiology evaluator’s comment that there are no further objections from a microbiological viewpoint, to the approval of the application to register Teduglutide (Revestive) 5 mg Powder for Solution for Injection Vial with Diluent Pre-filled Syringe. Clinical Indications Proposed: Revestive is indicated for the treatment of adult patients with SBS who are dependent on parenteral support. Proposed modified indication: Revestive is indicated for the treatment of adult patients with SBS who are dependent on parenteral support. Patients should be stable for at least 4 to 8 weeks on their parenteral support regimen before initiating teduglutide therapy. Pharmacology As an analogue of GLP-2, teduglutide increases intestinal and portal blood flow, and inhibit gastric acid secretion. Because it acts to increase absorption across the GI mucosa it
5 vials of each batch for testing by the TGA Laboratories Branch together with any necessary standards, impurities and active pharmaceutical ingredients (with their Certificates of Analysis) required for method development and validation. Samples and data should be forwarded to the Laboratories Branch, Biochemistry Section, before release of each batch and with sufficient lead time to allow for testing. Note: This release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation. Secondary evaluations as per the evaluator: Sufficient evidence has been provided to demonstrate that the risks related to the presence of adventitious agents in the manufacturing of Teduglutide (Revestive) have been controlled to an acceptable level. There are no further objections from a microbiological viewpoint to the approval of the application to register Teduglutide (Revestive) 5 mg Powder for Solution for Injection Vial with Diluent Pre-filled Syringe. Nonclinical There are no nonclinical objections to the registration of teduglutide. The nonclinical evaluator noted the inclusion of the recommended PI amendments in the revised PI submitted with the Section 31 response. The Sponsor has proposed an ECP specification of 75 ppm, and the mean batch level of ECP (16 ppm) exceeds the ARGPM Guidance 18 threshold of 10 ppm. Accordingly, clinical advice is sought regarding the suitability of these proposed levels of ECP in terms of clinical safety and registration. Clinical advice: The Delegate accepts the microbiology evaluator’s comment that there are no further objections from a microbiological viewpoint, to the approval of the application to register Teduglutide (Revestive) 5 mg Powder for Solution for Injection Vial with Diluent Pre-filled Syringe. Clinical Indications Proposed: Revestive is indicated for the treatment of adult patients with SBS who are dependent on parenteral support. Proposed modified indication: Revestive is indicated for the treatment of adult patients with SBS who are dependent on parenteral support. Patients should be stable for at least 4 to 8 weeks on their parenteral support regimen before initiating teduglutide therapy. Pharmacology As an analogue of GLP-2, teduglutide increases intestinal and portal blood flow, and inhibit gastric acid secretion. Because it acts to increase absorption across the GI mucosa it