Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) revealed on Thursday that FDA has awarded the authorization to Dupixent as an add-on cure for moderate-to-severe asthma in children from the age 6 to 11 years. Dupixent has currently gained authorization for the cure of asthma in sufferers between the age of 12 and above.
The decision of the FDA is expected to be on October 21, 2021, and the EU supervisory proposal for children aged 6 to 11 years with asthma is scheduled for Q1 2021. FDA has accepted the assessment of supplemental Biologics License Application (sBLA) for Dupixent. This is the greatest accomplishment of REGN and SNY in the development of Dupixent.
The sBLA is backed by the data comprises the pivotal Phase 3 results assessing the potency and protection of Dupixent plus the cure of moderate-to-severe asthma with type 2 inflammation in children. A study has proven that Dupixent has diminished the severe asthma attacks in children between the ages of 6 to 11 years. It has also shown an improvement in lung functions.
On the other hand, in the Phase 3 trial, the firms have also observed the adverse happenings that were more frequently witnessed with Dupixent. The adverse circumstances include injection site reactions, viral upper respiratory tract infections, and eosinophilia. The firm has disclosed that the complete results from this Phase 3 trial will be available later this year.
Currently, in the US alone nearly 75K children between the ages of 6 to 11 years have experienced moderate-to-severe asthma which has created a difficulty not for children but the families as well. This treatment of REGN and SNY is a ray of hope for the children and their families. Dupixent is a fully human monoclonal antibody that was developed by utilizing the patented VelocImmune technology of REGN.