AstraZeneca gets two more EU drug approvals

At the same time, alongside its partner Daiichi Sankyo, it said trastuzumab deruxtecan has been recommended for conditional marketing authorisation in the EU.

The FTSE 100 pharmaceuticals giant said the Trixeo Aerosphere approval was for maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who were not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist.

It said the approval was based on positive results from the ‘ETHOS’ phase 3 trial, in which Trixeo Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies ‘Bevespi Aerosphere’ and ‘PT009’ over 52 weeks.

The approval was also supported by efficacy and safety data from the ‘KRONOS’ phase 3 trial.

Trixeo Aerosphere was recommended for marketing authorisation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in October.

“Trixeo Aerosphere has a strong clinical profile compared with dual-combination therapies and offers an important new treatment option for patients with chronic obstructive pulmonary disease,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.

“In Europe, about one in 10 adults over the age of 40 has chronic obstructive pulmonary disease, with prevalence increasing.

“We look forward to discussing all-cause mortality data from the ETHOS phase 3 trial with health authorities.”

Meanwhile, AstraZeneca said the approval for trastuzumab deruxtecan was as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, who had received two or more prior anti-HER2 based regimens.

Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the registrational ‘DESTINY-Breast01’ phase 2 trial, published in the New England Journal of Medicine, and the results from the phase 1 trial published in the Lancet Oncology.

In the DESTINY-Breast01 trial, trastuzumab deruxtecan demonstrated clinically meaningful and durable activity in patients who had received two or more prior anti-HER2 medicines.

An updated analysis from DESTINY-Breast01 was presented last week at the 2020 San Antonio Breast Cancer Symposium, the company said, reinforcing the durable efficacy and long-term safety and tolerability profiles of trastuzumab deruxtecan.

“The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting,” said executive vice-president of oncology research and development, José Baselga.

“If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2-positive metastatic breast cancer.”

At 0848 GMT, shares in AstraZeneca were down 6.13% at 7,660p.