Cipla has announced that it has received US FDA approval for an innovative formulation — Lopinavir/ Ritonavir oral pellets for paediatric specific for the treatment of aids in infants and young children. “Long recognizing the lack of access to life saving child-friendly formulations for the treatment of HIV”, the company says “Cipla was prompted to develop an innovative formulation in pellets form that can be sprinkled on sweetened porridge for infants and administered to them. The pellets are produced by melt-extrusion technology and are enclosed in capsules.”
Globally 3,200,000 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% are currently on treatment. One third of the children born with HIV without treatment die before their first birthday and 50% die before they turn two.
Commenting on the development, 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. Cipla has been committed to the cause of HIV/AIDS for over two decades. 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: “This unique drug delivery system is a breakthrough in paediatric specific treatment for infants. The traditionally available antiretroviral liquid formulations and tablets have their own challenges when it comes to treating infants.”
Dr Peter Mugyenyi, Executive Director of the Joint Clinical Research Centre (JCRC) in Uganda and a leading International authority on treatment of HIV/AIDS in Africa said: “I am delighted to hear of Cipla’s breakthrough in getting US FDA approval. This product is a first step in making accessible more modern and appropriately formulated treatment available to the most vulnerable of HIV patients – young children.”