MHRA grants Promising Innovative Medicine Designation to Sanofi’s RSV drug

pharmafile | January 19, 2021 | News story | Manufacturing and Production MHRA, Sanofi 

The MHRA has granted a Promising Innovative Medicine (PIM) Designation to Sanofi’s nirsevimab, which is being investigated a passive immunisation for the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in all infants in their first RSV season, from birth and up to 12 months of age; and children with chronic lung disease or with haemodynamically significant congenital heart disease in their second RSV season, up to 24 months of age. 

RSV, a common, contagious virus that infects the respiratory tract, is the leading cause of LRTI 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.

Nirsevimab is a passive immunisation, whereby an antibody is given intramuscularly to an infant to help prevent RSV, unlike active immunisation, in which a person’s immune system is activated to produce antibodies to a pathogen to prevent or fight infection. Passive immunisation has the potential to offer immediate protection.

The PIM Designation was based on Phase IIb results of nirsevimab, which found a significant reduction in medically attended LRTI due to RSV in healthy preterm infants, compared to placebo. The results also showed nirsevimab achieved a 78.4% relative reduction in the incidence of hospitalisations due to RSV LRTI in healthy preterm infants, compared to placebo. Nirsevimab had a tolerable safety profile, with no significant hypersensitivity reactions observed.

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.”

Darcy Jimenez

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