New clinical data request hits Astra’s lung triplet

Astrazeneca’s hopes of challenging its respiratory rival Glaxosmithkline have taken a blow with a US FDA rejection for the company’s triple therapy, Breztri Aerosphere, in COPD. Astra is not saying much about the reasons for the complete response letter, but told Vantage that the agency had asked for more clinical data. Depending on what the FDA is after, this might not be the end of the world for Astra: the company recently reported that the Ethos study of Breztri Aerosphere – which was not included in the filing – met its primary endpoint of reducing exacerbations. But, even if the company does not need to carry out another trial, it could find it difficult to gain market share from Glaxo, which has made a surprise success of Trelegy Ellipta. Both projects combine a LABA, LAMA and steroid in one inhaler. There is also a new kid on the triplet block, Novartis, which this week reported a topline win with its contender, QVM149, in asthma; interestingly, Novartis does not appear to be studying this project in COPD.

The battle of the triplets: selected combo respiratory projects
Project Company Indication Status 2024e sales ($m)
Trelegy Ellipta Glaxosmithkline/Innoviva COPD Approved in US, EU 1,645
Asthma Phase III Captain trial met primary endpoint
Breztri Aerosphere/PT010  Astrazeneca COPD Approved in Japan, filed in EU, China; FDA CRL Sep 2019 505
Asthma Phase II
QVM149  Novartis/Sosei/Vectura Asthma Phase III Iridium trial met primary endpoint; filed in Europe 240
Source: EvaluatePharma, company releases.

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