When will long-acting injections be available in the UK?
Hi, do you know when injectable monthly medications and implants will become available in the UK? A doctor at a workshop I attended in November 2017 suggested it could be 2018.
Is this realistic?
Update (June 2021)
On 21 December 2021, the EU approved long-acting cabotegravir and rilpivirine injections.
Access in England will be decided by NICE in October 2021. The UK-CAB is coordinating community input to the meeting. Access will take up to three months from this meeting.
Update (September 2020)
On 29 July 2020, cabotegravir/rilpivirine injections (called Cabenuva) were resubmitted to the US FDA. This should mean a decision on US approval will be within the next 6-12 months.
Submission for EU approval was made a year ago so this decision is expected soon.
It will take another 9-12 months for the NHS to decide about access in the UK.
Update (July 2019)
The main results from both the ATLAS and FLAIR studies were presented at CROI 2019. Submission to FDA was made in July 2019 with a decision expected by the end of December 2019. The application to the EMA in Europe will follow shortly with a decision expected in early-mid 2020.
Phase 3 results with dual therapy cabotegravir/rilpivirine long-acting injections: ATLAS and FLAIR studies.
Named-patient/expanded access programmes are also now available for both long-acting formulation.
Thanks for your question as this is something lots of people are interested in. A friend even asked me this yesterday.
Unfortunately, 2018 sounds optimistic, unless you are already taking part in a research study. Regular approval on the NHS will probably not be until 2019 or more likely 2020.
Sometimes the timeline for drug development is difficult to predict. Research often takes longer than expected. As well as the early research this involves large phase 3 studies that usually need at least a year of results. Then the regulatory agency (ie the FDA in the US or EMA in Europe) takes 6 to 9 months to decide if the drug is safe and effective. In the UK, the NHS then takes another 6 to 12 months (at least) to decide if it will pay for the drug.
Currently, the phase 3 studies for long-acting cabotegravir plus rilpivirine are still ongoing. According to listed information online, the ATLAS and FLAIR studies are now fully enrolled. The first results are expected in June and September 2018, respectively. The company then needs several few months to compile the results. This means, if good, the regulatory agencies are unlikely to start evaluating long-acting injections until late 2018/early 2019. If approved later in 2019, the NHS will take at least until 2020 to decide if they will pay for access.
Links to each of these phase 3 studies is below:
- ATLAS (Antiretroviral Therapy as Long-Acting Suppression)
- FLAIR (First Long-Acting Injectable Regimen) study
This answer was updated in June 2021, September 2020 and April 2019 from an original Q&A posted in January 2018.