ULTIBRO BREEZHALER (indacaterol, glycopyrronium) long-acting bronchodilator
RESPIRATORY MEDICINE - Update
Opinions on drugs - Posted on Mar 29 2018
Reason for request
Re-assessment of the actual benefit and the improvement in actual benefit
Moderate clinical benefit in continuous bronchodilator treatment of chronic obstructive pulmonary disease
- ULTIBRO BREEZHALER has Marketing Authorisation in continuous bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
- The results of new data have led to the conclusion that this fixed combination of two long-acting bronchodilators has a moderate clinical benefit in this indication (and no longer substantial) in a population restricted to patients with moderate to very severe COPD whose symptoms are already controlled by the combination of indacaterol and glycopyrronium separately administered.
- ULTIBRO BREEZHALER is more specifically for patients with moderate to very severe COPD who have associated persistent dyspnoea despite use of a long-acting bronchodilator in monotherapy.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments