“Beyfortus: The New Effective Drug for Reducing Bronchiolitis Hospitalizations in Infants”

Next winter maybe bronchiolitis do not cause so much sleeplessness to the parents of the infants. The Interministerial Commission on Medicine Pricesin which the Ministry of Health and the communities participate, has proposed this Friday that the drug Beyfortusapproved by the EU in November and which has proven effective in reducing hospitalizations caused by respiratory syncytial virus (RSV) in infants financed totally or partially in Spain. It is one more step towards the inclusion of the innovative drug in the portfolio of services of the National Health System, although the Government and the autonomies have not yet decided in which specific situations it will be administered, within the calendar of vaccination -which is now called immunization–

The Public Health Commission held a technical meeting on the drug on Tuesday, but failed to reach a decision. The possible recommendations will be considered again in the next meetings, although Catalonia and Galicia they have already advanced their intention to administer it. The Government has even set a date: the next autumn. At the moment there is time for its inclusion in the common immunization schedule, given that RSV -which causes 80% of bronchiolitis and pneumonia in infants- is seasonal, it attacks mainly in winter and at the moment the incidence is low. The maximum peak last season was at the end of November and caused an intense collapse in hospital emergencies.

Precisely this Friday, at the annual meeting of the European society of pediatric infections (ESPID for its acronym in English), have been presented new data from a clinical trial in phase 3 showing that Nirsivamabwhich is marketed under the name Beyfortus, reduces hospitalizations caused by RSV by more than 80%, confirming its efficacy and favorable safety profile.

Antibody

The innovative drug contains a monoclonal antibody recombinant that is administered by a single intramuscular injection. Its use is indicated in babies from birth until the first season in which they can be infected with RSV, with an eye to ensuring that they are more protected when they first come into contact with the virus. In Canada, it is even approved for children up to 24 months of age who are still vulnerable to the disease, in order to protect them in their second season of contact with RSV as well.

He medicine has been co-developed by Sanofi and AstraZeneca, who announced an agreement to push and commercialize the antibody in 2017. Since then, it has been approved by various regulatory agencies around the world. In the US this drug adds to the recent approval of the Arexvy vaccine, developed by the British pharmaceutical giant CSK, which is indicated for adults age 60 and over, who are also victims of RSV. The European Medicines Agency (EMA) has also issued a favorable opinion on the vaccine, which could be included in the Spanish immunization schedule in the coming months.

The high incidence

RSV infections originate in Spain between 7,000 and 14,000 hospitalizations year. Between 2% and 3% of children with an infection in the first 12 months of life require hospitalization. Of that percentage, between 2% and 6% enter an intensive care unit. The risk of the infection becoming serious is higher in premature babies children under 6 months, babies with chronic lung problems, with congenital heart disease or who are immunocompromised.