Cipla gets USFDA approval for child-friendly HIV drug delivery system

Cipla, the Mumbai-based pharma major, announced on Wednesday that it has received approval from the US Food and Drug Administration (USFDA) for a new drug delivery system that can be used in treating infants and children suffering from HIV. Speaking to Business Today, Jaideep Gogtay, Chief Medical Officer, Cipla said: "Lopinavir/Ritonavir is a preferred antiretroviral in pediatric patents and this unique drug delivery system (of oral pellets) is a breakthrough in pediatric-specific treatment for infants. This is because as of now, if this is to be administered to infants, you have to use it in a liquid form which is quite unpleasant and has about 40 per cent alcohol in it because syrups are typically made like that. So, what is currently available in not child-friendly formulation." The US FDA approval is for Lopinavir/ ritonavir (LPV/r) 40mg/ 10 mg oral pellets for treatment for infants. According to a note issued by the company, "the pellets are to be sprinkled on sweetened porridge for infants and administered to them. The pellets are produced by melt-extrusion technology and are enclosed in capsules."

On the development of the new drug delivery system which is child-friendly, the company said: "Cipla has been working for many years in collaboration with Diana Gibb, Professor of Epidemiology, Senior Programme Leader and Honorary Consultant Pediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) towards development of this novel child-friendly formulation." According to Gogtay, "the product was developed in-house but we worked with Prof Gibb to understand the dosing and how it has to be delivered and administered because she is an expert in Paediatric HIV." Regarding the markets in which it could be made available, Gogtay said the company had just got the USFDA approval (under the President's Emergency Plan for AIDS Relief (PEPFAR) program) which meant it could sell in Africa and some other countries but not in the US, as it is still covered under patent.

On availability in India, he said, "we will be submitting our dossier for this to the drug controller's office in India and once an approval is received it can launch in India too." He however, refused to comment on the pricing, saying the company had only just got the approval.

The new drug delivery system is apparently important considering the magnitude of the problem. According to the statement released by the company announcing the FDA approval, "globally 3.2 million children were living with HIV in 2013 and 240,000 children were newly infected with HIV (UNAIDS - The Gap Report 2014). Although antiretroviral therapy can be life saving for these children, only 24 per cent are currently on treatment. One-third of the children born with HIV without treatment die before their first birthday and 50 per cent die before they turn two."