CHMP recommends CHF 5993 for maintenance treatment of COPD.- Chiesi Farmaceutici.

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 CHF 5993 from Chiesi Farmaceutici S.p.A., intended for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD).

CHF 5993 is a triple combination of an inhaled glucocorticoid (beclometasone dipropionate), a long-acting beta-2 receptor agonist (formoterol fumarate dihydrate) and a long-acting muscarinic antagonist (glycopyrronium bromide). It will be available as a pressurised metered dose inhaler delivering a solution with a nominal dose per actuation of 87 micrograms / 5 micrograms / 9 micrograms of the active substances respectively.

Beclometasone reduces inflammation in the lungs, whereas formoterol and glycopyrronium relax bronchial smooth muscle helping to dilate the airways and make breathing easier (ATC code: R03AL09). The benefits with CHF 5993 Chiesi Farmaceutici S.p.A. are its ability to relieve and prevent symptoms such as shortness of breath, wheezing and cough and to reduce exacerbations of COPD symptoms. The most common side effects of CHF 5993 Chiesi Farmaceutici S.p.A. are oral candidiasis, muscle spasm and dry mouth.

The application for CHF 5993 Chiesi Farmaceutici S.p.A. was an informed consent application. In an informed consent application, reference is made to an authorised medicine where the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure. The reference product for CHF 5993 Chiesi Farmaceutici S.p.A. is Trimbow. The full indication is: �Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist .