The MHRA (Medicine and Healthcare Products Regulatory Agency) has reportedly approved a PIM (Promising Innovative Medicine) designation to an extended half-life mAb (monoclonal antibody) called Nirsevimab. This antibody is reportedly undergoing examination as a passive immunization for the purpose of preventing LRTI (Lower Respiratory Tract Infections).
These infections are apparently caused in infants by the RSV (Respiratory Syncytial Virus) during the course of their first RSV season, which lasts between birth and up to one year of age. Records cite that LRTI is also observed in children having haemodynamically significant congenital heart disease or chronic lung disease through their second RSV season, which lasts up to two years of age.
As per sources, PIM Designations are granted to those medicinal products that are expected to provide a major advantage to patients. Nirsevimab’s PIM designation was reportedly awarded on the basis of the Phase 2b results and shows a considerable reduction in the medically aided LRTI on account of RSV in healthy preterm infants.
The results have also depicted that the success of Nirsevimab in the achievement of a relative reduction of 78.4 per cent in the incidence of hospitalizations due to RSV LRTI, when compared with placebo. Additional results state that Nirsevimab had an admissible safety profile, with no observation of remarkable hypersensitivity reactions.
According to Ian Gray, the Medical Director at Sanofi UK, even though RSV is a pervasive respiratory disease, there are currently no preventative options or approved treatments that are available to all infants. Therefore, MHRA’s PIM designation denotes that Nirsevimab is a promising alternative that would help in combating this still unmet requirement, added Gray.
The Medical Director has further marked this achievement as an exciting milestone that reflects the company’s deep dedication towards bringing a preventative alternative to all babies against this potentially severe and common respiratory virus.