AstraZeneca complete MRP for novel asthma treatment

AstraZeneca has successfully completed the European Union Mutual Recognition Procedure (MRP) for Symbicort Maintenance And Reliever Therapy (Symbicort SMART).

The new treatment approach enables patients to use one inhaler for both maintenance and relief of asthma symptoms.

Symbicort SMART is licensed for use in adults who need an inhaled corticosteroid (ICS) and a long acting bronchodilator (LABA) combination treatment. National approvals are expected to be issued throughout the EU over the coming months the company predicts.

When compared to traditional gold standard therapy, using multiple separate inhaler devices, Symbicort SMART is a more effective way to manage asthma, as it provides a simple way for patients to improve daily symptom control and reduce the risk of asthma attacks, AstraZeneca says

The treatment has been studied in a wide clinical trial programme involving over 14,000 patients with mild to severe persistent asthma.

Further data from the SMILE study, recently published in The Lancet, showed for the first time a positive effect of giving an inhaled steroid for daily maintenance and as-needed, to both prevent and treat symptoms. SMILE evaluated the benefits of different as needed therapies: budesonide/formoterol, formoterol or terbutaline on top of Symbicort maintenance therapy, in preventing asthma attacks. The use of as-needed budesonide/formoterol provided increased protection from severe attacks compared with terbutaline as-needed on top of Symbicort maintenance therapy.

In addition, the use of budesonide/formoterol as-needed was significantly more effective than formoterol as-needed on top of Symbicort maintenance therapy.