Novartis’ COPD combo show benefits in switching from established drugs

A new study suggests COPD patients experience improved lung function and breathlessness after direct switch from long-acting bronchodilators or steroid containing combination therapies to Novartis’ Ultibro Breezhaler..

The trial should help Novartis to persuade doctors and patients to switch from their tried-and-tested COPD medicines, as both can be fearful of losing control of the disease in a change of medication.

The CRYSTAL trial is the first large-scale study exploring the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate COPD from their current treatments.

This includes steroid-containing combinations and long-acting bronchodilators, to the dual bronchodilator Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg.

Novartis’ Ultibro Breezhaler is one of a new generation of treatments competing to take over from standard treatments such as GSK’s Advair/Seretide, Boehringer Ingelheim’s Spiriva and AstraZeneca’s Symbicort.

Its biggest competitor is GSK, which also has a new dual bronchodilator Anoro Ellipta.  Results from GSK’s combination have underwhelmed until now, and failed to show superiority to the older drugs in head-to-head trials.

Novartis, by contrast, can claim superiority, and say the Ultibro Breezhaler is also currently the only steroid-free treatment to offer prescribers clinically proven superiority over the most prescribed ICS/LABA combination in preventing COPD exacerbations.

However GSK recently revealed that its new ‘closed triple therapy’ has shown very strong results in reducing COPD exacerbations in its FULFIL study.

GSK’s combination brings together Fluticasone furoate an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered in a single once-daily dose in GSK’s Ellipta dry powder inhaler.

Novartis says its results support recommendations put forward by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which said dual bronchodilation should be the foundation treatment for the majority of symptomatic COPD patients.

In the CRYSTAL study, patients with moderate COPD who were switched to Ultibro Breezhaler from their previous therapy (LABA+ICS* or LABA or LAMA) experienced superior improvements in lung function (trough FEV1) and breathlessness at week 12.

The CRYSTAL study is the first LABA/LAMA pragmatic trial, designed to mimic clinical practice, so treatment switching occurred without a washout period.

“Today’s results are significant as they show for the first time the positive effect of directly switching to Ultibro Breezhaler from other COPD treatments, such as inhaled steroid-containing combination therapies,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “By showing that improved symptom control can be achieved through using Ultibro Breezhaler, the CRYSTAL study provides further support to limit the use of inhaled steroid-containing therapies to specific patient types that really need it.

Nevertheless, GSK and its FULFIL study could take the lead in the COPD market, with its new triple therapy filed last month,  and a 2017 approval in the US and Europe on the cards.

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