Safety considerations may be raised by the nonclinical and clinical evaluators and/or the Nonclinical and Clinical Evaluation Reports respectively. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. The sponsor has considered the relevance for the RMP of all safety considerations raised in the Nonclinical and Clinical Evaluation Reports. All of the clinical evaluator comments relevant to the RMP have been addressed. The sponsor does not believe that any nonclinical safety issues have been raised that would result in further revisions to the RMP. The sponsor’s response has been noted. Any ASA updates should be provided in the current ASA format. The sponsor has updated the RMP to comply with the current ASA format and has assigned a version number. This is considered acceptable in the context of this application. The ASA should be assigned a version number. The sponsor has updated the RMP to comply with the current ASA format and has assigned a version number. As above. The sponsor should supply all of the A revised HCP training program presentation, based on a similar training program offered in the US and Canada, as The original sponsor submission
proposed materials related to additional risk minimisation activities, including but not limited to the missing modules of the proposed health care professional training program. well as the proposed injection training video and questionnaire to be administered post-training, specifically measure of effectiveness have been supplied including the training program/questionnaire and the injection video as an example from the US training program. did contain modules 2, 3, and 5 of the then proposed health care professional training program. Modules 1 and 4 (and potentially other modules) were missing. The sponsor should state which topic areas the missing modules contain and submit them. ‘Injection site should be as an Important Identified Risk. ‘Injection site anaesthesia/paraesthesia’ has been added to the RMP as an Important Identified Risk. This is considered acceptable in the context of this application. ‘Injection site bleeding’ should be added as an Important Identified Risk. Although there were very few verbatim reports of ‘bleeding’, ‘injection site bleeding’ has been added to the RMP as an Important Identified Risk. Additionally, in response to RMP requests, a statement has been added to the PI regarding injection site bleeding and patients who have risk factors for bleeding events. As ‘Injury of structures at or near the injection site’ should be added as an Important Potential Risk. ’Injury of structures at or near the injection site’ has been to the RMP as an Important Potential Risk. As above ‘Dysphagia‘ should be added as an Important Potential Risk. Since a small number of cases were reported in clinical trials, the sponsor considers dysphagia to be an identified risk. Therefore, ‘Dysphagia’ has been added to the RMP as an Important Identified Risk. As above.
supporting the safe and efficacious use of Belkyra in the treatment of submental fullness associated with submental fat. The training materials will reinforce training only in the labelled indication and specify that safe and effective use has not been established outside of the submentum. HCPs will understand who the appropriate Belkyra patient is, how to evaluate and define the treatment area, and how to safely inject the product. HCPs will learn strategies to manage patient expectations and comfort during and following treatment with Belkyra to support adherence to and achievement of desired aesthetic goals. The sponsor believes that this training program will be sufficient to ensure that only appropriately qualified HCPs will be allowed to purchase Belkyra. good understanding of the relevant anatomy. So-called cosmetic physicians or other medical practitioners without formal evidence of sufficient familiarity with head and neck anatomy should not be able to prescribe or administer this product, and subsequently should not be supplied with it. The HCP training program should include the indications and for Belkyra. Furthermore, the program should include information on assessing causes of submental swelling for which Belkyra is not an appropriate treatment option. The training program includes the indications and contraindications for Belkyra. Additionally, training includes an overview of the causes of submental swelling for which Belkyra is not an appropriate treatment option. The sponsor’s response has been noted. The education materials will be reviewed again after a final PI is available. A rudimentary understanding of the training materials is not considered sufficient to A comprehensive training program has been created for Belkyra. Please see the above responses for a description of the questionnaire proposed as a measure of effectiveness of training materials. Also, please see proposed questionnaire that has As