When new anti-asthma biologics come to the door, always give them a welcome seat. Here is an anti- atopic dermatitis monoclonal antibody that also shuts down a key component of the allergy airway inflammation pathway, now a 12 and up asthma therapy. Dr. Susarla
- Sanofi and Regneron have won an expanded U.S. approval for Dupixent in asthma, securing another indication for the biologic drug which the companies are counting on to deliver blockbuster sales.
- On Friday, the Food and Drug Administration OK'd the drug for moderate-to-severe asthma patients with an eosinophilic phenotype, or with oral corticosteroid-dependent asthma regardless of phenotype, the companies said. The new indication adds to Dupixent's previously approved use for moderate-to-severe atopic dermatitis.
- Clinical results supporting the approval showed Dupixent cut severe asthma attacks by 67% compared to placebo in patients with high eosinophil counts. Among patients with lower levels of the inflammation marker, however, Dupixent did not separate from placebo in statistical comparison.