Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Relvar Ellipta, 184 mcg/22 mcg and 92 mcg/22 mcg, inhalation powder, predispensed intended for the regular treatment of asthma and Relvar Ellipta, 92 mcg/22 mcg, inhalation powder, predispensed for the symptomatic treatment of chronic obstructive pulmonary disease ( COPD ).
Relvar Ellipta is a fixed-dose combination of the active substance Fluticasone furoate, a synthetic corticosteroid with potent anti-inflammatory activity, and the active substance Vilanterol, a selective long-acting beta2-receptor agonist.
Beta2-receptor agonists stimulate intracellular adenylate cyclase which converts adenosine triphosphate ( ATP ) into cyclic adenosine monophosphate ( AMP ). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
The benefits with Relvar Ellipta in the symptomatic treatment of COPD are its ability to improve the weighted mean forced expiratory volume ( FEV1 ) 0-4 hours at day in six-month studies versus placebo and to improve the annual rate of moderate and severe exacerbations in one-year clinical studies versus Vilanterol 25 mcg.
The benefits with Relvar Ellipta in the regular treatment of asthma are its ability to improve trough FEV1 in a 24-week study comparing the 184-mcg / 22-mcg strength versus placebo, Fluticasone furoate 200 mcg and Fluticasone propionate 1000 mcg and to reduce the number of severe exacerbations in a 24-week study comparing the 92-mcg / 22-mcg strength versus Fluticasone furoate 100 mcg.
The most common side effects are headache and nasopharyngitis and upper-respiratory-tract infections. Cases of pneumonia have been reported in patients taking Relvar Ellipta in both indications. Pneumonia has been included as an important identified risk in the risk-management plan and the applicant will conduct two post-authorisation safety studies to further investigate this risk.
The approved indications are:
a) Asthma - Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years old and older where use of a combination medicinal product ( long-acting beta2-agonist and inhaled corticosteroid ) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists.
b) COPD - Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 less than 70% predicted normal ( post-bronchodilator ) with an exacerbation history despite regular bronchodilator therapy.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Relvar Ellipta and therefore recommends the granting of the marketing authorisation. ( Xagena )
Source: EMA, 2013
XagenaMedicine_2013
