EMA Panel Recommends Ibalizumab for Multidrug-Resistant HIV-1

Troy Brown, RN


July 29, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended on July 26 marketing authorization for ibalizumab (Trogarzo, Theratechnologies International Limited) for the treatment of patients with multidrug-resistant HIV-1 infection.

"The positive recommendation from the CHMP gives European patients reasons to hope that they could soon have access to Trogarzo. If approved, Trogarzo will address an important unmet medical need for patients in Europe. It will be the first antiretroviral with a new mechanism of action to be approved in Europe in the past 11 years," Christian Marsolais, PhD, senior vice president and chief medical officer, Theratechnologies, said in a company news release.

Ibalizumab is a monoclonal antibody (ATC code: J05AX23) that inhibits HIV from entering target cells by binding to CD4. It will be marketed as a 200-mg concentrate for an infusible solution. Ibalizumab is intended to be administered in combination with other antiretroviral medications to adults with multidrug-resistant HIV-1 infection for whom other antiviral suppression regimens are not options.

The US Food and Drug Administration approved ibalizumab for multidrug-resistant HIV-1 on March 6, 2018.

The committee proposed that only physicians with experience treating patients with HIV disease prescribe ibalizumab.

The most frequently seen adverse effects are diarrhea, vomiting, rash, and dizziness; there have also been reports of immune reconstitution inflammatory syndrome.

The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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