Lopinavir/Ritonavir Pellets for Children Tentatively Approved by the FDA
On 21 May 2015, the U.S. FDA tentatively approved lopinavir/ritonavir (LPV/r) 40/10mg pellets manufactured by Cipla for infants and young children less than three years old.
This is the first solid form of LPV/r for this age group. The World Health Organization (WHO) recommends LPV/r-based regimens as preferred for infants and young children. Compliance with the recommendation has been difficult as this boosted protease inhibitor was previously only available as syrups, which are too complicated to use for many programmes in low- and middle-income countries.
The Drugs for Neglected Diseases initiative (DNDi) is waiting for the production of the clinical batch of the pellets to begin the LIVING study (implementation study using the new formulation) in Kenya. All the necessary regulatory approvals are in place in Kenya to start.
DNDi is working on an improved taste masked granule formulation of LPV/r (a component of a fixed dose combination 4-in-1 regimen), which will be tested in HIV negative adults very soon.
We hope that this approval will lead to early access for young children to a solid LPV/r-based formulation.
- U.S. Food and Drug Administration. Tentative approval letter. (21 May 2015).