GSK 18 months ahead of the game with three-drug inhaler

pharmafile | November 21, 2016 | News story | Medical Communications, Sales and Marketing GSK, Innoviva, chronic obstructive pulmonary disease 

GlaxoSmithKline, alongside its partner Innoviva, have filed a regulatory submission with the FDA for its treatment for chronic obstructive pulmonary disease (COPD).

The treatment is a once-daily, closed triple combination therapy that contains fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The medicine will be adminisitered through a dry powder inhaler.

The condition which it treats, COPD, is a disease of the lungs that includes chronic bronchitis, emphysema or both. The conditions are typified by obstruction to airflow that interferes with normal breathing. There are a potential 329 million sufferers worldwide. There is, therefore, a large market for this type of treatment and GSK/Innoviva will be happy that they have managed to file their regulatory submission as early as possible. It is expected that they will also place a regulatory filing in the EU in the coming weeks. This could see them move ahead of rivals AstraZeneca and Novartis in the race to offer the ‘closed triple’ therapies.

Dave Allen, head of respiratory R&D, said, “COPD is a progressive disease and its impact on patients can worsen over time. As reflected in the recently updated GOLD COPD Strategy*, for those patients with advanced disease, multiple therapies such as ICS/LAMA/LABA combinations are often required and are typically delivered via two or more inhalers with potentially differing dose regimens. This first regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies.”

Ben Hargreaves

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