Drug Watch: Agents in late-stage development for the treatment of pulmonary diseases (March 2009) (PDF)

If approved, Ofev would be the first approved treatment for children and adolescents with fibrosing interstitial lung disease. A decision is expected in the fourth quarter of this year.

Tezspire is a biologic that specifically targets the inflammation associated with asthma.

Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.

Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.

If approved the vaccine, RSVpreF, would be available for people 60 years of age and older. The Prescription Drug User Fee Act goal date for a decision is in May 2023.

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.