Date: 2018-09-14
Type of information: Acceptation for review of a NDA
Product name: Trogarzo™
Compound: ibalizumab
Therapeutic area: Infectious diseases
Action mechanism:
- monoclonal antibody. Ibalizumab is a CD4-directed HIV entry-inhibitor and is the first humanized monoclonal antibody in clinical trials for the treatment of HIV. Ibalizumab was designated a Breakthrough Therapy by the FDA based on preliminary clinical evidence indicating that it may represent a substantial improvement over existing therapies on one or more clinically significant endpoints. In a Phase IIb clinical trial, conducted on 113 patients, the product significantly reduced viral load in multi-drug resistant HIV-infected patients.
The US FDA has also granted ibalizumab Orphan Drug designation.
Company: TaiMed Biologics (Taiwan) Theratechnologies (Canada)
Disease:
- HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy
Latest news:
- • On September 14, 2018, Theratechnologies announce dthat the EMA has confirmed the validity of the marketing authorization application for Trogarzo™ (ibalizumab) filed on August 28, 2018. The validation confirms the submission is complete, and begins the EMA’s centralized review process. As a result, the start of procedure date has been set to September 13, 2018.
- • On August 28, 2018, Theratechnologies announced that the application for marketing authorization of Trogarzo™ (ibalizumab) was filed with the EMA through its centralized procedure. The EMA has until mid-September to confirm whether the application is complete, in which case, it will initiate the review of Trogarzo™ under the accelerated assessment procedure. The application is based on the same clinical trial data that was reviewed by the FDA to grant marketing authorization of Trogarzo™ in the United States.
- • On July 31, 2018, Theratechnologies announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency will review the application for marketing authorization of Trogarzo™ (ibalizumab-uiyk) injection under the accelerated assessment procedure. The accelerated assessment procedure reduces the timeframe for a recommendation by the CHMP to 150 review days from 210 review days for the normal procedure.
- • On April 30, 2018, Theratechnologies announced that its novel antiretroviral Trogarzo™ is now commercially available in the United States.
• On March 6, 2018, the FDA approved Trogarzo™ (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Trogarzo™ is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
- The safety and efficacy of Trogarzo™ were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. Many of the participants had previously been treated with 10 or more antiretroviral drugs. The majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression.
- The clinical trial focused on the small patient population with limited treatment options and demonstrated the benefit of Trogarzo in achieving reduction of HIV RNA. The seriousness of the disease, the need to individualize other drugs in the treatment regimen, and safety data from other trials were considered in evaluating the Trogarzo development program.
A total of 292 patients with HIV-1 infection have been exposed to Trogarzo IV infusion. The most common adverse reactions to Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system (immune reconstitution syndrome).
- Trogarzo™ previously received Breakthrough Therapy and Orphan Drug designations as well as Priority Review status from the FDA, underscoring the significance of the treatment for this patient population.
- • On June 30, 2017, Theratechnologies announced that it has been notified by its partner, TaiMed Biologics., that the FDA has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014.
- • On May 3, 2017, Theratechnologies announced that its partner, TaiMed Biologics, has completed the submission of a Biologics License Application (BLA) to the FDA for ibalizumab for the treatment of multidrug resistant HIV-1. If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. As ibalizumab has received the Breakthrough Therapy and Orphan Drug Designations, TaiMed has requested Priority Review for the application.
- The ibalizumab BLA is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017.
- • On October 20, 2014, the FDA has granted orphan drug designation for ibalizumab for the treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Patents:
Submission of marketing authorization application USA : 2017-05-03
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2018-03-06
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-10-20
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
- • On July 25, 2018, Theratechnologies announced that Trogarzo™ (ibalizumab-uiyk) injection is now included in the most recent version of the treatment guidelines issued by the International Antiviral Society-USA Panel (“IAS”). The guidelines were published in the Journal of the American Medical Association (“JAMA”).
- The new IAS guidelines state that “Ibalizumab, an anti-CD4 monoclonal antibody that inhibits HIV cell entry via CD4 binding, is active against CCR5- and C-X-C chemokine receptor 4 (CXCR4)–tropic HIV isolates and may be useful as a fully active agent for patients with multiclass-resistant virus (evidence rating BII). Almost 50% of adults with virologic failure from multidrug-resistant HIV achieved undetectable HIV RNA levels at 24 weeks after receipt of biweekly intravenous ibalizumab (800 mg) with at least 1 other active drug.”
- • On May 23, 2018, Theratechnologies announced that it has reached a pricing agreement with the AIDS Drug Assistance Program Crisis Task Force. The agreement opens access to Trogarzo™ (ibalizumab-uiyk) injection to low income, underinsured and uninsured Americans in all 50 states and the territories.
Is general: Yes
