Europe: Virology CHMP Minutes for November 2022

Summary:   Minutes from the EMA’s Committee for Medicinal Products for Human Use (CHMP) meeting on 7-10 of November 2022 released on the 18th of January 2023. Items of interest listed below:

Post-authroisation issues  

Trogarzo (ibalizumab) – Theratechnologies Europe Limited 

• Indication: treatment of adults infected with HIV-1 resistant to at least 1 agent in 3 different classes 
• The CHMP noted the withdrawal of the marketing authorisation.

POST-AUTHORISATION PROCEDURES OUTCOMES

Juluca (dolutegravir / rilpivirine) - ViiV Healthcare B.V. 

• Positive Opinion adopted by consensus together with the CHMP assessment report and translation timetable. 
• The CHMP was of the opinion that the renewal of the marketing authorisation can be granted with unlimited validity

POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES

Cabotegravir; Vocabria (cabotegravir) - ViiV Healthcare B.V. 

• The CHMP, having considered in accordance with Article 28 of Regulation (EC) No 726/2004 the PSUR on the basis of the PRAC recommendation and the PRAC assessment report as appended, recommends by consensus, the variation to the terms of the marketing authorisation for the above-mentioned medicinal product, concerning the following change: Update of section 4.8 of the SmPC to amend the adverse reaction “Type I hypersensitivity” by the adverse reaction “Hypersensitivity” with same frequency. The package leaflet is updated accordingly.

START OF THE PROCEDURES  

Cabotegravir  

• Indication: pre-exposure prophylaxis of HIV-1 infection