FDA News

FDA approves Trogarzo for MDR HIV

The FDA today approved Trogarzo — a long-acting humanized monoclonal antibody — for the treatment of multidrug-resistant HIV in adults who are failing their current ART regimens. The drug previously received breakthrough therapy and orphan drug designations and was granted priority review by the agency.

Trogarzo (ibalizumab-uiyk), which was developed by Theratechnologies in partnership with TaiMed Biologics, is the first HIV therapy with a new mechanism of action approved in 10 years, according to a news release. The drug is administered intravenously once every 14 days and used in combination with other antiretroviral medications. The FDA said patients should receive a single loading dose of 2,000 mg, followed by a maintenance dose of 800 mg every 2 weeks.

“Today’s approval of [ibalizumab-uiyk] by the FDA is great news for people infected with difficult-to-treat multidrug-resistant (MDR) HIV,” Luc Tanguay, president and CEO of Theratechnologies, said in the release. “We look forward to bringing this much-needed therapy to patients in the U.S. within 6 weeks.”

The approval was based on the phase 3 TMB-301 study, which included 40 heavily treatment-experienced patients with MDR HIV. After 24 weeks of treatment with ibalizumab-uiyk, patients achieved a mean reduction in HIV-1 RNA of 1.6 log, and 48% had a reduction of more than 2 log. In addition, 43% of patients had undetectable viral loads and 50% had a viral load of less than 200 copies/mL. Data presented at IDWeek showed that 59% patients were virally suppressed after 48 weeks of treatment.

As previously reported, ibalizumab-uiyk reached its primary endpoint, with 83% of patients achieving at least a 0.5 log10 decrease in HIV-1 RNA by day 14 (P < .0001).

According to the FDA, 292 patients with HIV-1 infection have been exposed to IV infusions of ibalizumab-uiyk, and the most common adverse reactions to the drug were diarrhea, dizziness, nausea and rash. Severe adverse events included rash and immune reconstitution syndrome.

References:

Emu B, et al. Abstract 449LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 13-16, 2017; Seattle.

Emu B, et al. Abstract 1686. Presented at: IDWeek; Oct. 4-8, 2017; San Diego.

Lewis S, et al. Abstract 438. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 13-16, 2017; Seattle.

Lalezari J, et al. Abstract LB-6. Presented at: IDWeek; Oct. 26-30, 2016; New Orleans.

Disclosure: Tanguay is employed by Theratechnologies.

The FDA today approved Trogarzo — a long-acting humanized monoclonal antibody — for the treatment of multidrug-resistant HIV in adults who are failing their current ART regimens. The drug previously received breakthrough therapy and orphan drug designations and was granted priority review by the agency.

Trogarzo (ibalizumab-uiyk), which was developed by Theratechnologies in partnership with TaiMed Biologics, is the first HIV therapy with a new mechanism of action approved in 10 years, according to a news release. The drug is administered intravenously once every 14 days and used in combination with other antiretroviral medications. The FDA said patients should receive a single loading dose of 2,000 mg, followed by a maintenance dose of 800 mg every 2 weeks.

“Today’s approval of [ibalizumab-uiyk] by the FDA is great news for people infected with difficult-to-treat multidrug-resistant (MDR) HIV,” Luc Tanguay, president and CEO of Theratechnologies, said in the release. “We look forward to bringing this much-needed therapy to patients in the U.S. within 6 weeks.”

The approval was based on the phase 3 TMB-301 study, which included 40 heavily treatment-experienced patients with MDR HIV. After 24 weeks of treatment with ibalizumab-uiyk, patients achieved a mean reduction in HIV-1 RNA of 1.6 log, and 48% had a reduction of more than 2 log. In addition, 43% of patients had undetectable viral loads and 50% had a viral load of less than 200 copies/mL. Data presented at IDWeek showed that 59% patients were virally suppressed after 48 weeks of treatment.

As previously reported, ibalizumab-uiyk reached its primary endpoint, with 83% of patients achieving at least a 0.5 log10 decrease in HIV-1 RNA by day 14 (P < .0001).

According to the FDA, 292 patients with HIV-1 infection have been exposed to IV infusions of ibalizumab-uiyk, and the most common adverse reactions to the drug were diarrhea, dizziness, nausea and rash. Severe adverse events included rash and immune reconstitution syndrome.

References:

Emu B, et al. Abstract 449LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 13-16, 2017; Seattle.

Emu B, et al. Abstract 1686. Presented at: IDWeek; Oct. 4-8, 2017; San Diego.

Lewis S, et al. Abstract 438. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 13-16, 2017; Seattle.

Lalezari J, et al. Abstract LB-6. Presented at: IDWeek; Oct. 26-30, 2016; New Orleans.

Disclosure: Tanguay is employed by Theratechnologies.