30th May 2018 07:45
LONDON (Alliance News) - AstraZeneca PLC and MedImmune, its global biologics research and development arm, said on Wednesday the Terranova trial - the second of two "pivotal" Phase III trials for Fasenra - did not meet its primary endpoint.
The Terranova trial failed to reach the primary endpoint of a statistically-significant reduction of exacerbations in patients with chronic obstructive pulmonary disease.
"These results are disappointing because uncontrolled COPD patients already on dual or triple inhaled therapy need new treatment options. We will now analyse the complete data sets from the GALATHEA and TERRANOVA trials to further understand these results," said Sean Bohen, executive vice president, global medicines development and chief medical officer.
A full evaluation of the data is ongoing, and the results will be submitted for presentation at a forthcoming medical meeting. Astra added that it does not currently intend to make a regulatory submission.
This announcement comes just weeks after Astra earlier in May said the Galathea Phase III trial for Fasenra did not meet its primary endpoint.
Fasenra is AstraZeneca's first respiratory biologic and is currently approved as an add-on treatment for severe eosinophilic asthma in the US, EU, Japan and "several other countries". The results of the Galathea and Terranova trials do not impact the approved indication in severe eosinophilic asthma, Astra said.
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