Revoca su rinuncia del titolare AIC per Trogarzo, farmaco per l'HIV

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed in its meeting agenda for November 2022 the withdrawal of Theratechnologies' Trogarzo (ibalizumab) MA in the EU. 

Trogarzo was approved in 2019 with the following indication:

"Trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen."

This decision is a confirmation of the earlier decision of the company to cease the commercialization in the EU (while still marketed in the US), due to unsatisfactory pricing and reimbursement conditions resulting in continuing losses for the company.

The Company has sent a notice of termination to TaiMed Biologics Inc. (TaiMed): as per contractual obligations will return the European commercialization rights to Trogarzo^® for TaiMed within the next 180 days. TaiMed is currently considering options for the continued commercial availability of Trogarzo in Europe.

source: CHMP meeting minutes