Paediatric dispersible formulation of dolutegravir submitted to EMA and FDA

13 December 2019. Related: Antiretrovirals.

Polly Clayden, HIV i-Base

On 13 December 2019, ViiV Healthcare submitted new drug applications to both the FDA in the US and to the EMA in the EU, for a new paediatric formulation of the integrase inhibitor dolutegravir. [1]

The new formulation uses film-coated dispersible 5 mg tablets, including in children from 4 weeks to 18 years old.

These submissions to the EMA and FDA are based on data from the ongoing phase 3 P1093and ODYSSEY (PENTA20) studies. [2, 3, 4, 5]

If approved this will enable children globally to be able to use comparable treatments to adult care.

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Through a partnership with CHAI and Unitaid, ViiV are providing support and technical transfer to generic manufacturers (Mylan and Macleods) to develop dispersible scored 10 mg DTG tablets to accommodate WHO paediatric weight bands with fewer tablets/formulations.

This process will include submission to the FDA for Tentative approval as well and support expediated roll out once the products are available.

References

1. ViiV press release. ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV. (13 December 2019).
   https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-files-submissions-to-the-fda-and-ema-for-the-first-ever-dispersible-formulation-of-dolutegravir-dtg-for-children-living-with-hiv
   
2. clinicaltrials.gov. PH3b, DTG study in HIV-1 subjects completing IMPAACT study P1093.
   https://clinicaltrials.gov/ct2/show/NCT03016533
3. clinicaltrials.gov. A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART.
   https://clinicaltrials.gov/ct2/show/NCT02259127
4. Clayden P. Dolutegravir for younger children: results from the ODYSSEY trial. HTB. 23 August 2019.
   https://i-base.info/htb/36584https://i-base.info/htb/36027
5. Clayden P. Dolutegravir update. HTB. 30 April 2019.
   https://i-base.info/htb/36027