FDA approves breakthrough drug for HIV patients with dwindling options

FDA approved a new drug that offers hope for patients with multidrug-resistant HIV-1 infection.

Ibalizumab-uiyk injection (Trogarzo, Theratechnologies and TaiMed Biologics), when used in combination with other antiretroviral treatments (ARTs), is indicated for heavily treatment-experienced patients with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.

Trogarzo is also the first HIV therapy with a new mechanism of action approved in 10 years and proven effectiveness in difficult-to-treat patients with limited options. Unlike all other classes of ARTs, Trogarzo is a CD4-directed post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells.

Related: FDA approves first generic Truvada for HIV

Up to 25,000 patients have multidrug-resistant HIV, and approximately 12,000 are in “dire need of a new treatment option,” Theratechnologies said in a statement.

“The approval of Trogarzo is important because it offers a new treatment option for a community in desperate need of one. The therapy reduces viral load in patients whose virus cannot be controlled with currently available treatments, and may increase T-cell levels, strengthening the immune system,” Luc Tanguay, president and CEO of Theratechnologies, told FormularyWatch. “Additionally, lowering the virus to undetectable levels is beneficial to public health as it can help prevent the transmission of infection.”   

The wholesale acquisition cost for Trogarzo will be $118,000 annually. “The wholesale acquisition cost does not factor in rebates and distribution costs, which means that the average net selling price should be approximately 30% lower that the wholesale acquisition cost,” Tanguay said.

Related: FDA gives once-daily HIV therapy go-ahead

In fact, the majority of patients will pay less than $25 per infusion in out-of-pocket costs for Trogarzo, according to Tanguay.

“We have built a distribution system to get Trogarzo to people where they need it. People who need Trogarzo can access it in the privacy of their own home, in a provider's office, or at an infusion center, depending on their insurance carrier and preference,” Tanguay said.

In the phase 3 clinical trial for Trogarzo, more than 80% of patients achieved the study's primary end point: at least a 0.5 log₁₀ (or 70%) viral load reduction from baseline seven days after receiving a 2,000 mg loading dose of Trogarzo-without adjustment to the failing background regimen.

The average viral load reduction after 24 weeks was 1.6 log₁₀ with 43% of patients achieving undetectable viral loads.

Trogarzo likely will be available within 6 weeks after approval, according to a statement.

Read more: Top 5 pipeline drugs for 2018