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Theratechnologies’ last-ditch HIV drug approved by FDA

The injectable becomes an add-on treatment for patients who have previously taken ART


An antibody drug that will provide a new treatment option for people with multidrug-resistant HIV has been approved in the US.

Theratechnologies Trogarzo (ibalizumab-uiyk) has been given the green light by the FDA as an add-on treatment for people who have had a lot of exposure to antiretroviral therapies (ART) in the past and are struggling to suppress levels of the virus despite combination therapy.

The intravenous drug - which acts differently from all other currently available HIV medicines - is given every two weeks on top of a patient’s current ART regimen. It binds to a particular region of the CD4 T-cell receptor and is thought to prevent HIV from infecting cells without having a negative impact on immune function.

Commenting on the approval, the FDA’s director of the division of antiviral products, Jeff Murray, said: “Most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs.”

However, “a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death”, he added.

According to its Canadian developer Trogarzo is the first drug with a new mechanism to be approved in a decade, has no interactions with other ARTs and no cross-resistance. It picked up orphan drug and breakthrough designations from the FDA on its way to approval, which the company said “underscores the significance of the treatment for this patient population”.

The company has said it intends to launch the drug with an annual price of $118,000 in the next few weeks, and has been ramping up its salesforce in anticipation of approval over the last six months. The company’s chief executive Luc Tanguay has said he expects sales to build gradually as reimbursement becomes available.

The high price reflects that the patient population addressed by Trogarzo is fairly small. In fact, the main trial used to support approval was conducted in just 40 subjects - many of whom had been treated with 10 or more different ART drugs - and all told less than 300 people have been treated with the drug to date.

Theratechnologies - which licensed Trogarzo from Taiwan’s TaiMed Biologics in 2016 - has also set up a subsidiary in Ireland with a view to moving quickly ahead with an EU filing for Trogarzo.

Article by
Phil Taylor

7th March 2018

From: Regulatory



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