Posted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the FDA’s thinking about preventive treatments for HIV as well as treatments for paediatric patients with HIV.
The first guidance, “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis,” addresses the overall development program and clinical trial designs to support the development of systemic drug products for the prevention of HIV-1 infection. The guidance provides sponsors with nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, including small molecules and monoclonal antibodies. This guidance finalises the draft guidance issued in June 2018.
The second guidance issued today titled “Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment” provides general recommendations on the development of antiretroviral drug products for the treatment of HIV infection in paediatric patients. It addresses when to initiate paediatric studies and offers approaches for enrolment of subjects into paediatric studies to help facilitate drug development. This guidance finalises draft guidance issued in May 2018.
