Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ultibro Breezhaler, 85 mcg/43 mcg, inhalation powder, hard capsule intended for maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease ( COPD ).
Ultibro Breezhaler is a fixed-dose combination of the active substances Indacaterol, a beta-2-adrenergic agonist, and Glycopyrronium bromide, an anticholinergic.
Indacaterol activates the relaxation of the muscles of the airways, and Glycopyrronium blocks the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
The benefits with Ultibro Breezhaler are its ability to relieve symptoms in adult patients with chronic obstructive pulmonary disease ( COPD ).
The most common side effects are the beta-adrenergic and anticholinergic symptoms related to the individual components of the combination.
The most frequently reported side effects in clinical trials with Indacaterol were: nasopharyngitis, upper respiratory tract infections, cough and headache.
Dry mouth, difficulty urinating, headaches, diarrhea and constipation are common side effects of the Glycopyrronium bromide.
The approved indication is: Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease ( COPD ).
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Ultibro Breezhaler. ( Xagena )
Source: European Medicines Agency ( EMA ), 2013
XagenaMedicine_2013
