Lung diseases

Asthma

• Beclometason / formoterol / glycopyrroniumbromide ^IND
• Depemokimab

• Formoterol / glycopyronium / budesonide

  • Budesonide/glycopyrronium/formoterol monotherapy for treatment of severe inadequately controlled Asthma in adolescents, adults and elderly.

COPD

• Dupilumab

  • Add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils for patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
• Itepekimab

• Mepolizumab

  • Nucala is indicated in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) (see section 5.1).

• Tozorakimab

  • Tozorakimab monotherapy for treatment of symptomatic Chronic obstructive pulmonary disease in adults and elderly with history of COPD exacerbations.

Cystic fibrosis

• Ivacaftor / Tezacaftor / Elexacaftor

  • Extension of the indication for Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) in a combination regimen to include the treatment of patients with cystic fibrosis (CF) aged 2 years and older who do not carry any F508del mutations and have at least one ivacaftor/tezacaftor/elexacaftor-responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
  • Treatment of cystic fibrosis (CF) in paediatric patients aged 1 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene).
• Vanzacaftor / tezacaftor / deutivacaftor

Lung diseases other

• Alpha-1 antitrypsin
• Brensocatib
• Nerandomilast
• Ralinepag

• Riociguat

  • Riociguat monotherapy for treatment of Chronic thromboembolic pulmonary hypertension in children over 6 years of age and adults.

• Sotatercept

  • Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV (see section 5.1).
  • Treatment of pulmonary arterial hypertension.

• Tezepelumab

  • Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.

• Treprostinil

  • Treprostinil monotherapy for treatment of idiopathic pulmonary fibrosis in adults over 40 years of age and elderly.

Unknown

• Colistimethaatnatrium ^IND
• Molgramostim