Generic versions of injectable PrEP could enable access to CAB-LA in low-income countries

Simon Collins, HIV i-Base

On 30 March 2023, the Medicines Patent Pool (MPP) announced that three Indian generic companies have signed licenses to be able to manufacture lower-priced versions of ViiV Healthcare’s long-acting PrEP drug cabotegravir (CAB-LA). [1]

This is an essential step before injectable PrEP could become widely available globally to low-income countries where rates of new HIV infections are still highest.

CAB-LA was approved as PrEP by the US FDA in December 2021 where it had already been approved as a component in long-acting HIV treatment. It was developed by ViiV Healthcare who markets the PrEP formulation under the trade name Apretude.

Even in the US, access to PrEP has so far been very limited because of the high price.

Last year, ViiV Healthcare signed a voluntary licensing agreement to make CAB-LA available to MPP after community pressure for the need for generic versions, notably from the AfroCAB. Previously, ViiV had announced that they would produce CAB-LA globally. [2, 3, 4]

The three generic companies included in today’s announcement are Aurobindo, Viatris (through its subsidiary Mylan) and Cipla who will all manufacture CAB-LA in India. Cipla also plans to manufacture CAB-LA in South Africa.

The press statement makes no reference to the timelines that will be needed before generic CAB-LA becomes available, or the likely generic prices.

However, research from the Clinton Health Access Initiative (CHAI) reported that generic formulations of CAB-LA injections could be produced at around $15-23 for a year’s course of six injections. [5]

CAB-LA for PrEP is also approved in Australia and Zimbabwe and was submitted to the EMA in Europe in December 2022. It has also been submitted in South Africa, Malawi, Botswana, Brazil, Kenya, Uganda, Vietnam, Malaysia, Myanmar, Philippines and China. [6]

References

1. MPP press statement. Medicines Patent Pool signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of ViiV Healthcare’s innovative long-acting HIV prevention medicine. (30 March 2023).
   https://medicinespatentpool.org/news-publications-post/medicines-patent-pool-signs-sublicences-with-aurobindo-cipla-and-viatris-to-produce-generic-versions-of-viiv-healthcares-innovative-long-acting-hiv-prevention-medicine
2. ViiV licenses long-acting cabotegravir (CAB-LA) for generic access. HTB (June 2022).
   https://i-base.info/htb/42974
3. AfroCAB. Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs. (1 March 2022).
   http://www.afrocab.info/2022/03/communities-demand-viiv-gsk-accelerate-access-to-cab-la-in-lmics (link page)
   http://www.afrocab.info/wp-content/uploads/2022/03/CAB-LA-Community-Statement-Final_v2.pdf (PDF statement)
4. FDA press release. FDA approves first injectable treatment for HIV pre-exposure prevention. (21 December 2021).
   https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention
5. Ripin D. Approach for delivery of long-acting ARVs for treatment and prevention in LMICs: cabotegravir as a precedent-setting case study. LEAP conference, March 2022.
   https://longactinghiv.org/files/inline-files/DavidRipin-LEAP2022.mp4 (MP3 recording)
6. i-Base. Cabotegravir-LA submitted to EMA for use as PrEP in Europe. HTB (December 2022).
   https://i-base.info/htb/44319

This report was first published on 1 April 2023.