In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on January 08 – 11, 2024. Following the meeting, a decision was made that safety-related changes need to be introduced to the registration materials/instructions for medical use of medicinal products containing semaglutide.
Semaglutide (semaglutide) – OZEMPIC; RYBELSUS; WEGOVY – PSUSA/00010671/202305
Based on the assessment of Periodic Safety Update Reports (PSURs), the PRAC reviewed the benefit/risk balance of the medicinal products OZEMPIC (semaglutide), RYBELSUS (semaglutide), and WEGOVY (semaglutide) and provided the following recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of the medicinal products OZEMPIC (semaglutide), RYBELSUS (semaglutide), and WEGOVY (semaglutide) for the approved indications remains unchanged.
- Nevertheless, the instructions for medical use should be updated by adding intestinal obstruction as an adverse reaction with the frequency “unknown” and by including the drug interaction between the use of semaglutide and other coumarin derivatives. Accordingly, the existing provisions of the instructions for medical use must be amended1.
- In the next PSUR, the registration certificate holder (RCH) must provide a cumulative review of cases of altered skin sensation following treatment with the medicinal product Rybelsus (semaglutide) and cases of hair loss with the use of the medicinal products Ozempic (semaglutide) and Rybelsus (semaglutide), based on post-marketing data. The RCH must also provide a cumulative review of cases of psychosis and psychotic disorders following concomitant use of semaglutide and antiparkinsonian agents. In addition, the RCH must discuss the results of precautionary measures related to medication errors with Wegovy (semaglutide). Finally, the RCH, like other RCHs of GLP-1 agonists, must continue to closely monitor cases of thyroid cancer as part of routine pharmacovigilance and/or in ongoing category 3 PASS (post-authorization safety study) as part of the risk management plan, as necessary, and report any new evidence regarding this association as part of PSUR submission.
1Update of the sections “Interaction with other medicinal products and other forms of interaction” and “Adverse reactions” of the instructions for medical use. The risk assessment report and the PRAC recommendation are forwarded to the CHMP for a decision.
List of medicinal products containing semaglutide (semaglutide) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 17.09.2024).
TO SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS, FOR ANALYSIS OF THE PUBLISHED INFORMATION:
