Ibalizumab approved in the EU
15 November 2019. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 26 September 2019, the European Medicines Agency (EMA) approved ibalizumab as a treatment for adults with HIV multidrug resistance. [1]
Ibalizumab is a monoclonal antibody that works by interfering with post-attachment steps for HIV to infect a CD4 cell. It is given by intravenous infusion every two weeks and needs to be used in combination with other active HIV drugs. Ibalizumab needs an initial loading dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks.
Approval is based on combined results in less than 300 people during the long clinical development phase, which has been ongoing for at least a decade.
For full details, please see the prescribing information and summary of product characteristics. [2]
Ibalizumab was approved by the US FDA in March 2018. [3]
Ibalizumab was developed by TaiMed Biologics with the trade name Trogarzo. It is marketed by Theratechnologies.
comment
Ibalizumab can be a life-saving option for people with multidrug resistance, with the potential to contribute a >1 log drop in viral load (based on monotherapy data).
This is likely to be needed for a very small number of UK patients – and as a bridging therapy until new oral drugs become available.
Access in the UK will depend on NHS commissioning, but this might be expedited due to urgency of need. Doctors should also contact Theratechnologies to ask about compassionate or named patient access.
Although a UK price has not been released, US list price is US $118,000 (WAC/Wholesale Acquisition Cost).
An expanded access programme fostemsavir is also now available from ViiV Healthcare and using both compound might be essential for people using ibalizumab.
Reference
- Theratechnologies PR. European Commission approves ibalizumab. (26 September 2019).
https://theratechnologies.s3.amazonaws.com/prod/media/Trogarzo_EU_approval_E.pdf (PDF) - The European patient information and detailed Product Information for Ibalizumab are posted to this link at the European Medicines Agency (EMA) website.
https://www.ema.europa.eu/en/medicines/human/EPAR/trogarzo - FDA press release. FDA approves new HIV treatment for patients who have limited treatment options. (06 March 2018).
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm?