FDA Approval For Cipla’s Child-Friendly HIV Drug Formulation

A novel pediatric formulation of anti-retroviral drugs could be life saving for children living with HIV.

AsianScientist (Aug. 12, 2015) – Cipla Limited, a global pharmaceutical company headquartered in India, has received US FDA approval for a child-friendly formulation of anti-retroviral drugs. The Lopinavir/ritonavir (LPV/r) 40 mg/10 mg oral pellets are designed to be sprinkled on sweetened porridge for infants.

The pellets, produced by melt-extrusion technology, are the result of a collaboration with Dr. Diana Gibb, Professor of Epidemiology, Senior Program Leader and Honorary Consultant Pediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London). This drug has been approved by US FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR) program.

Commenting on the development, Mr. Subhanu Saxena, MD & global CEO, Cipla Ltd. said: “We are extremely proud to have developed this innovative formulation of LPV/r oral pellets for infants and young children. This innovative way of drug delivery through oral pellets for some of society’s youngest AIDS sufferers reiterates our commitment to provide access to life-saving medicines in the fight against HIV/AIDS.”

Dr. Jaideep Gogtay, chief medical officer, Cipla Ltd. said: “The traditionally available anti-retroviral liquid formulations and tablets have their own challenges when it comes to treating infants. LPV/r oral pellets 40 mg/10 mg should be used in combination with other anti-retroviral agents for the treatment of HIV-I infection in pediatric patients weighing five kg and above and who can have semi-solid food.”

Globally 3,200,000 children were living with HIV in 2013 and 240,000 children were newly infected with HIV, according to a UNAIDS report. Although anti-retroviral therapy can be life saving for these children, only 24 percent are currently on treatment. One third of the children born with HIV without treatment die before their first birthday and 50 percent die before they turn two.

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Source: Cipla; Photo: NIAID/Flickr/CC.
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