By Ludwig Burger and Justin George Varghese
(Reuters) – Prospects for AstraZeneca’s respiratory treatments business improved on Wednesday as a three-drug inhaler was shown to ease smoker’s lung and U.S. regulators granted its injectable asthma drug Fasenra special status for a rare lung condition.
AstraZeneca said the late-stage ETHOS trial of triple-drug therapy Breztri Aerosphere, formerly known as PT010, helped patients suffering from chronic obstructive pulmonary disease (COPD), in a challenge to Glaxosmithkline’s Trelegy Ellipta.
Colloquially known as smoker’s lung, COPD is a progressively worsening and potentially deadly condition that affects more than 380 million people worldwide, primarily caused by smoking but also by occupational hazards such as air pollution or chemical fumes.
Breztri was shown to lower the risk of a recurrence in flare-ups, or exacerbations, when compared to standard two-drug inhalers, adding to previous evidence https://www.astrazeneca.com/media-centre/press-releases/2018/the-lancet-respiratory-medicine-publishes-first-phase-iii-trial-for-pt010-triple-combination-therapy-in-moderate-to-very-severe-chronic-obstructive-pulmonary-disease-16092018.html#! that the drug helped those without prior exacerbations.
The British drugmaker is seeking to catch up with domestic rival GlaxoSmithKline’s Trelegy Ellipta, which generated 156 million pounds ($192 million) in sales from COPD last year.
“We believe the Breztri clinical profile is going to be highly competitive,” said Tom Keith Roach, Astra’s Vice President for the respiratory therapy area, though more trial readouts were needed for better comparison.
He added there was a broader range of patients for which Breztri was shown to reduce exacerbations and, in addition, two dosage forms of Breztri could in future be available to fine-tune the COPD treatment, if regulators can be convinced.
AstraZeneca also said on Wednesday that the U.S. Food and Drug Administration granted orphan drug status to its Fasenra injection to treat a rare allergic inflammation of the esophagus.
That could pave the way for a faster approval against eosinophilic esophagitis for the drug.
It is already cleared for the treatment of severe asthma, competing with GSK’s Nucala and Teva’s <TEVA.TA> Cinqair.
(Reporting by Ludwig Burger in Frankfurt and Justin George Varghese in Bengaluru ; Editing by Bernard Orr and Louise Heavens)