AstraZeneca's Breztri scores in COPD trial, amping its case for triple-combo battle against GSK

Could "orphan drug" status for Fasenra and a Breztri trial win give AstraZeneca a leg up in its battle against GlaxoSmithKline? (AstraZeneca)

AstraZeneca and GlaxoSmithKline have long locked horns in their battle for respiratory supremacy with the latter holding the clear advantage in triple-drug inhaler market. Can another round of positive data for its combo inhaler give AZ a leg up?

AZ’s triple-drug COPD med Breztri Aerosphere significantly reduced the rate of exacerbations for patients with chronic obstructive pulmonary disease over its own dual-drug treatments, according to data from the phase 3 Ethos trial released Wednesday.

Also on Wednesday, the FDA gave orphan drug status to AZ’s Fasenra to treat eosinophilic esophagitis, an ultra-rare disease that currently has no approved treatments from the FDA, the drugmaker said. The designation comes with seven years of exclusivity, apart from patent protection, among other benefits.

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Taken together, the advances in AZ’s respiratory portfolio underscore the British drugmaker’s escalation of its battle with countryman GSK for dominance in the field—particularly in triple combos, where GSK holds the upper hand.

RELATED: AstraZeneca's COPD triplet Breztri, rival to GSK's Trelegy, nabs first nod from Japan

Breztri, currently approved to treat COPD in Japan but unapproved in the U.S., faces an uphill battle against GSK’s Trelegy Ellipta, which has a clear lead in the triple-drug inhaler category. But the Wednesday data could offer a bit of an edge: Both doses of Breztri beat the two-drug combos, and as the trial investigator noted, that could give doctors more flexibility in prescribing.

The triple inhaler is already under review at the FDA and European Medicines Agency, but Mene Pangalos, EVP of biopharma R&D at AstraZeneca, said the company looks forward to passing the new data along to regulators "as soon as possible."

The new data augment the phase 3 Kronos, unveiled in September, which showed Breztri beat AZ’s Symbicort and other two-drug inhalers at improving forced expiratory volume in one second (FEV1)—which measures breathing ability—at almost all points over a period of 24 weeks.

At the time, Breztri fell short on the same metrics in comparison to two-drug Bevespi, but AZ noted that Breztri did post a numerically favorable trend, just not a strong enough one to pass the statistically significant threshold.

Now, with a Japan approval in tow and regulatory reviews underway in Europe and the U.S., AZ is hoping it can get a piece of Trelegy’s market-leading £120 million in second-quarter sales.

RELATED: AstraZeneca's Fasenra offers severe asthma patients 2 years of benefits: analysis

In the meantime, AZ can rest easy knowing it will push GSK with its other respiratory drugs as it waits for the triple combos to catch up. Case in point: Fasenra, which hit $296 million in the first half of 2019—a whopping 244% increase over the previous year.

AZ touted the fact that Fasenra, despite being the third product to launch in eosinophilic asthma, had led the way as the biologic of choice for new-to-prescription patients.

Fasenra is fighting against a familiar foe, GSK’s Nucala, as well as Teva’s Cinqair and Novartis’ Xolair, which hasn’t yet been approved to treat eosinophilic asthma. For Nucala, which has struggled to keep up with Fasenra's more convenient dosing regimen, an FDA greenlight in June for two new delivery devices—a self-administered autoinjector and a prefilled syringe—could present a challenge to AZ's drug.  

With Fasenra’s performance on the upswing, AZ posted 5% growth for its respiratory franchise on the whole in the first half, with $2.5 billion in sales.

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