FDA approves oral pellets for HIV/Aids treatment of infants

Cipla Medpro CEO, Paul Miller

Developed by Cipla, the pellets, produced by melt-extrusion technology and enclosed in capsules, are sprinkled on sweetened porridge for infants for administration.

Cipla has long recognized the lack of access to life saving child-friendly formulations for the treatment of HIV, which prompted it to develop an innovative formulation of LPV/r oral pellets. It has been working for many years in collaboration with Diana Gibb, Professor of Epidemiology, Senior Programme Leader and Honorary Consultant Paediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) towards development of this novel child-friendly formulation, which has been approved by US FDA under the President's Emergency Plan for AIDS Relief (PEPFAR) programme.

Commenting on the development, Paul Miller CEO, Cipla Medpro said, "We are extremely proud to have developed this innovative formulation of LPV/r oral pellets for infants and young children. The company 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, added, "Lopinavir/Ritonavir is a preferred antiretroviral in paediatric patents and 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. The oral pellets should be used in combination with other antiretroviral agents for the treatment of HIV-I infection in paediatric patients weighing 5 kg and above, who can have semi-solid food."

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 the company's breakthrough in getting US FDA approval for the world's first paediatric Lopinavir and Ritonavir oral pellets for the treatment of AIDS in infants and young children. The reason I welcomed Dr Y K Hamied's invitation to sit on the Cipla Board as an independent board director is because its motto of 'None shall be denied' and its dedication to work for patients who are most in need. 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."

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.