Trogarzo · HIV infection
Development and Regulatory status
Jul 19: recommended for EU approval by CHMP - the full indication is "in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen." It is proposed that the medicine should be prescribed by physicians experienced in the treatment of HIV disease. .
Apr 19: Theratechnologies announces that the Scientific Advisory Group HIV/Viral Diseases (SAG), convened by the Committee for Medicinal Products for Human use (CHMP) in Europe, has given a positive recommendation to Trogarzo® (ibalizumab). The recommendation from the CHMP to the European Medicines Agency is expected to be announced around May 29, 2019 .
May 18: Filed in EU for HIV-1 infections (in treatment experienced patients, IV).
Mar 18: Approved in the US
Nov 17: FDA announces extension of target action date to 3/4/18 .
May 16: Theratechnologies has exclusive rights to market and distribute the drug for the IM route of administration. Theratechnologies has exclusive rights to commercialize ibalizumab in the US and in Canada. TaiMed will continue to be responsible for development of ibalizumab and seek approval from the FDA, whereas Theratechnologies will be responsible to obtain the approval from Health Canada .
May 16: Ibalizumab has been awarded Breakthrough Therapy status by the FDA, as well as orphan status, based on preliminary clinical evidence indicating that it may represent a substantial improvement over existing therapies on one or more clinically significant endpoints .
Jan 16: TaiMed Biologics initiates a rolling BLA for ibalizumab with the US FDA. The whole rolling submission process including pre-approval inspection is planned for completion in 2016. On completion of the ongoing PIII trial, the regulatory application will be evaluated under priority review by the US FDA and is expected to complete latest by H1 2017 
Trial or other data
Oct 18: Ibalizumab is the most advanced mAb in testing, but there are other candidates undergoing trials--including VRC01 . It is first in a new class of antiretrovirals, providing a treatment option for multidrug resistant HIV-1 patients .
Aug 18: Results of PIII study (NCT02475629) published in NEJM. 25 week study (n=40) found ibalizumab (IB) had significant antiviral activity with 33 (83%) experiencing decrease in viral load of ≥ 0.5 log10 copies/mL from baseline (p<0.001 vs. control period). Diminished IB susceptibility was seen in vitro in patients with virologic failure .
Feb 18: Study TMB-311 (NCT02707861) still recruiting. Estimated primary completion date listed as Aug 17.
May 16: Canadian specialty pharma Theratechnologies and its biotech partner TaiMed Biologics post positive top-line results for the first-ever antibody HIV treatment. Ibalizumab hit its primary end point in a PIII trial in patients with multidrug-resistant HIV-1. Preliminary results show that 82.5% of patients enrolled in the TMB-301 study (33 out of 40 patients) have met the primary endpoint of a decrease of ≥ 0.5 log10 in viral load following a 7-day treatment period with ibalizumab .
Mar 16: TaiMed Biologics and Westat initiated an expanded access PIII trial to assess the safety and tolerability of ibalizumab IV combined with an optimised background regimen for the treatment of patients with multi-drug resistant HIV-1 infections (TMB-311; NCT02707861). The non-randomised, parallel, open-label trial is recruiting 50 patients in the US .
Aug 15: TaiMed Biologics initiates a PIII trial to evaluate the safety and efficacy of ibalizumab, in combination with an optimised background regimen of antiretroviral medications, in treatment-experienced patients with multi-drug resistant HIV-1 infections (TMB-301; NCT02475629). 36 patients will be enrolled in the US, Puerto Rico and Taiwan. Top-line data for the primary endpoint are anticipated by end of May 16 .