The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted ‘promising innovative medicine’ (PIM) designation to a medicine being developed by Sanofi.
Nirsevimab, an extended half-life monoclonal antibody, is being investigated as a passive immunisation for the prevention of lower respiratory tract infections caused by respiratory syncytial virus (RSV) in very young children.
PIM designations are given to medicinal products that are likely to offer a major advantage for patients with the potential to address an unmet medical need.
Ian Gray, Sanofi UK Medical Director said: “RSV is a pervasive respiratory disease, yet no approved treatments or preventative options available to all infants currently exist. The MHRA’s PIM Designation indicates nirsevimab is a promising option to help combat this still unmet need.
“This exciting milestone reflects our deep commitment to bringing a preventative option to all babies against this common and potentially severe respiratory virus.”
RSV is a common, contagious virus that infects the respiratory tract, is the leading cause of LRTI-such as bronchiolitis and pneumonia in infants and young children. By two years of age, nearly all children have been infected by RSV at least once.
RSV results in millions of hospitalisations globally and nearly 60,000 deaths in children under five years of age every year.