EU Panel Recommends Approval for 6 COPD, Asthma Drugs

Megan Brooks


February 21, 2014

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) this week recommended approval of 6 inhaled medications for treatment of respiratory diseases.

Four are intended for treatment of adults with chronic obstructive pulmonary disease (COPD), and 2 are intended for treatment of asthma and COPD.

The drugs for COPD are as follows:

  • The combination of the long-acting muscarinic antagonist umeclidinium bromide (55 µg) and the long-acting β2 agonist vilanterol (22 µg), under the brand names Anoro and Laventair, both from GlaxoSmithKline;

  • Umeclidinium bromide (55 µg) as monotherapy, under the brand name Incruse (GlaxoSmithKline), as reported February 20 by Medscape Medical News;

  • The long-acting β2 agonist indacaterol (85 µg) combined with the anticholinergic glycopyrronium bromide (43 µg), under the brand name Ulunar Breezhaler, from Novartis.

The 2 drugs receiving a positive CHMP opinion for treatment of adults with asthma and COPD are the combination of the inhaled corticosteroid budesonide and the long-acting β2 agonist formoterol, under the brand names of DuoResp Spiromax and BiResp Spiromax. Both are from Teva Pharma.

The budesonide/formoterol fixed dose combination (160/4.5 µg or 320/9 ug per dose) is recommended for patients whose condition is not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting β2 adrenoceptor agonists, or for patients whose disease is already adequately controlled with both inhaled corticosteroids and long-acting β2 adrenoceptor agonists, and in the symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular therapy with long-acting bronchodilators, the CHMP said.

On the basis of quality, safety, and efficacy data submitted, the CHMP considers there to be a favorable benefit-to-risk balance for all 6 medicines and therefore recommends the granting of the marketing authorization. A pharmacovigilance plan for all 6 drugs will be implemented as part of the marketing authorization, the CHMP said.

Detailed recommendations for the use of these products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages if the marketing authorization is granted by the European Commission.


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