On October 26, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has reached an agreement with the Italian Medicines Agency, AIFA, for the reimbursement of Trogarzo for eligible people aged 18 and older living with multi-drug resistant (MDR) HIV-1 (Press release, Theratechnologies, OCT 26, 2021, View Source [SID1234596237]).
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"This agreement is an important milestone for Trogarzo and for HIV-1 patients in Italy," said Conor Walshe, General Manager, Europe. "Italy is the first country with a universal healthcare plan that has approved the formal reimbursement of Trogarzo for all patients in need. We expect to launch Trogarzo in Italy during the current quarter and look forward to its wider commercial availability in Europe over the coming months."
Trogarzo was first approved by the U.S. Food and Drug Administration (FDA) in March 2018 and was the first long-acting agent approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with MDR HIV-1 infection failing their current antiretroviral regimen. Trogarzo was approved by the European Medical Agency (EMA) in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen and is also commercially available in Germany. A number of patients are also being treated with Trogarzo in other European countries through early access programs. Theratechnologies plans to launch Trogarzo on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company received regulatory approval in Israel for Trogarzo and is working to secure pricing and reimbursement.
About Trogarzo1
Trogarzo a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.
Trogarzo blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with the post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. Trogarzo is administered every 2 weeks via intravenous infusion.
The most frequently reported adverse reactions were rash (9.2%), diarrhea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).