Sanofi’s nirsevimab has been awarded a Promising Innovative Medicine (PIM) designation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for the prevention of respiratory syncytial virus (RSV) associated lower respiratory tract infections (LRTI).
Nirsevimab is an extended half-life monoclonal antibody (mAb) currently being investigated as a passive immunisation for the prevention of LRTI caused by RSV in all infants from birth and up to 12 months of age.
It is also being evaluated in children with chronic lung disease or with haemodynamically significant congenital heart disease in their second RSV season - up to 24 months of age.
The PIM designation was awarded on the basis of Phase IIb results of nirsevimab, which found a significant reduction in medically attended LRTI due to RSV in healthy preterm infants compared to placebo.
In addition, nirsevimab also demonstrated a 78.4% relative reduction in the incidence of hospitalisations caused by RSV-associated LRTI in healthy preterm infants compared to placebo.
"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,” said Ian Gray, medical director, Sanofi UK.
“This exciting milestone reflects our deep commitment to bringing a preventative option to all babies against this common and potentially severe respiratory virus.”
RSV causes millions of hospitalisations globally and nearly 60,000 deaths in children under five years of age every year.