Health extends the indication of the RSV vaccine

The AEMPS is listed in the Bulletin of the Committee for Medicinal Products for Human Use in July 2024

August 8, 2024. 12:26 p.m

The Spanish Agency for Medicines and Health Products (AEMPS), which belongs to the Ministry of Health, has reported the expansion of the indication for the vaccine ‘Arexvy’ to prevent respiratory syncytial virus infection (RSV) in adults between 50 and 59. years. The vaccine, which was produced by the GSK laboratory, was until now only approved for people over 60 years old. This was announced by the AEMPS in the Bulletin of the Committee for Medicinal Products for Human Use in July 2024, where they issued positive comments for new indications for various medicines.

Arexvy brand extension

As stated in that bulletin, Arexvy is indicated for active vaccination to prevent lower respiratory tract infection (LRTI) caused by respiratory syncytial virus in adults 60 years of age and older, and now also in adults 50 to 50 years of age who have the greatest risk of getting an RSV infection. The use of this vaccine should be based on official recommendations. This vaccine has been available in Spain since last May, but only for adults over 60 years old, although GSK already announced in October 2023 positive test results for its use in the age group 50 to 59 years old. Therefore, its effectiveness was evaluated in adults aged 50 to 59 years, including those who were at increased risk of lower respiratory tract infection (LRTD) caused by RSV due to underlying comorbidities. The vaccine induced an immune response in adults aged 50 to 59 years at increased risk of RSV infection due to selected underlying comorbidities that was not inferior to that seen in adults aged 60 years and older.

Other news

Among the publications in the new AEMPS journal, ‘Braftovi’ (encorafenib) also stands out, with a new indication for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. Until now it was indicated for melanoma and colorectal cancer. Similarly, the new indication for ‘Edurant’ (rilpivirine), a drug for the treatment of HIV-1 in pediatric patients from 2 to less than 18 years of age, weighing at least 14 kg and less than 25 kg. This is now on a new dosage form of 2.5 milligram disintegrating tablets, and previously it was 25 milligram film-coated tablets.