dm+d

Unassigned

New Medicines

RukobiaHIV infection

Information

Rukobia
New molecular entity
ViiV Healthcare
ViiV Healthcare

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
September 2021
Sep 21Rukobia 600mg sustained-release, film-coated tablets available in the UK. Price for 60 tablets = £2900.00 [23].
Feb 21Approved in EU (and UK) [20].
Dec 20Recommended for EU approval by CHMP - the full indication is, in combination with other antiretrovirals, "for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen." It is proposed that the medicine be prescribed by physicians experienced in the management of HIV infection [19]
Jul 20Approved in US for treatment of adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. [17].
Feb 20EMA are reviewing MAA under accelerated assessment programme [15].
Jan 20A marketing authorisation application has been submitted to the European Medicines Agency seeking approval of fostemsavir [13].
Dec 19Filed in US [12].
Jul 19ViiV does have plans to file in the EU/UK [11].
Jul 19BMS has previously decided that it no longer plans to file for this indication [10].
Feb 18PIII (NCT02362503) study ongoing. Estimated date for collection of primary outcome data is now April 2020.[7]
Jul 17Primary completion date of PIII study NCT02362503 now 2020 [5]
Dec 15Viiv plans regulatory filings by 2018 [3].
Dec 15BMS sells fostemsavir to GlaxoSmithKline-controlled ViiV Healthcare [3].
Jul 15Granted breakthrough therapy status in US [1].

Category

Antiretroviral designed to prevent HIV attachment to and entry into CD4+ T cells, first-in-class.
In 2017, ~ 84,725 people in England were living with HIV and 78,000 were aware of their infection. Of these, 90% are treated and 3% fail to achieve viral suppression following treatment which indicates multi-drug resistance. [14]
HIV infection
Oral

Further information

NICE has decided it will not appraise fostemsavir in this indication

Trial or other data

Nov 20NICE TA development stopped. The Topic Selection Oversight Panel concluded that an appraisal of fostemsavir in combination with other antiretroviral treatment for multidrug-resistant HIV-1 would be of limited value to the NHS at this time and therefore the topic will not progress any further [21].
Oct 20In the PIII BRIGHTE study (n=371), rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96 in the randomised cohort. Response rates in the non-randomised cohort were 37% (37 of 99) at week 24 and week 96 [18].
Mar 20PIII BRIGHTE study (n=371) is published; in patients with limited treatment options, fostemsavir added to their failing regimen (randomised, blinded for 8 days) was associated with a larger reduction in HIV-1 RNA level at day 8 than placebo (difference of -0.63 log10 copies per mL; 95% CI -0.81 to -0.44; p<0.001) [16].
Nov 18ViiV announce positive data from PIII BRIGHTE study (NCT02362503). At 48 weeks, 54% of patients in randomised cohort achieved virologic suppression (<40copies/mL) with fostemsavir in combination with optimised background therapy [8].
Feb 18PIII (NCT02362503) study ongoing. Estimated date for collection of primary outcome data is now April 2020.[7]
Jan 17PIII (NCT02362503) study is currently recruiting patients. Estimated date for collection of primary outcome data remains Aug 18 [4].
Jul 15PIII (NCT02362503) study is currently recruiting 410 pts from global sites including the US and EU (incl. UK). Collection of the primary outcome is due to complete Aug 18 [2].
Jul 15Breakthrough therapy designation is based on data from the PIIb study comparing BMS-663068 to a boosted protease inhibitor (Reyataz® - atazanavir sulfate) and ritonavir) in treatment-experienced patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate. Week 48 results from the PIIb trial were presented earlier this year at the 22nd Conference on Retroviruses and Opportunistic Infections [1].
Jul 15BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors´ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus´ initial interaction with immune cells entirely, and thus blocks its entry into the cell [1].
Jul 15PIII trial in heavily treatment-experienced patients (defined as individuals who can no longer formulate a viable three-drug treatment regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications) begins [1].

Evidence based evaluations