14th Dec 2020 10:07
(Alliance News) - AstraZeneca PLC on Monday received approval to market Trixeo Aerosphere, which treats severe chronic obstructive pulmonary disease, in the EU, while EU approval was recommended for Trastuzumab Deruxtecan, a breast cancer treatment developed together with Daiichi Sankyo Co Ltd.
The Cambridge-based biopharmaceutical drug maker said that, in the Ethos Phase III trial, Trixeo Aerosphere showed a a statistically significant reduction in the rate of moderate or severe exacerbations of COPD compared with dual-combination therapies Bevespi Aerosphere and PT009 over 52 weeks.
Following the positive results, it had been recommended for EU marketing authorisation in October. Trixeo Aerosphere already was approved as a treatment for COPD under the brand name Breztri Aerosphere in Japan, China and the US.
Separately, AstraZeneca received a positive European regulatory opinion for Trastuzumab Deruxtecan as monotherapy treatment for patients with unresectable or metastatic human epidermal growth factor receptor 2-positive breast cancer, who have received two or more previous anti-HER2 based regimens. Conditional marketing authorisation was recommended by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
AstraZeneca worked with Tokyo-based pharmaceutical peer Daiichi Sankyo on the Destiny-Breast01 Phase II trial, which highlighted the "durable efficacy and long-term safety and tolerability" of the drug for patients with HER2-positive breast cancer.
Daiichi Sankyo Senior Vice President Gilles Gallant said: "Trastuzumab deruxtecan is already available for patients with HER2-positive metastatic breast cancer in the US and Japan, and we are now one step closer to bringing this important new medicine to patients in Europe."
Shares in AstraZeneca were down 4.9% at 7,762.92 pence in London while shares in Daiichi Sankyo closed down 1.1% at JPY3,349 in Tokyo on Monday.
By Zoe Wickens; [email protected]
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