Events in the second half of fiscal 2018
In the second half of fiscal 2018, major news is expected for indications in diabetes, anemia, COPD (chronic obstructive pulmonary disease), and lupus in AstraZeneca’s (AZN) pipeline. A data readout is expected from the DECLARE trial for Farxiga for type 2 diabetes, and a regulatory decision in the European Union is expected for the Bydureon autoinjector for type 2 diabetes. The company also expects a data readout for roxadustat for anemia.
AstraZeneca expects a regulatory decision in the European Union and a regulatory submission in Japan for Bevespi for COPD, as well as a regulatory submission for PT010 and Fasenra targeted at COPD and a data readout for anifrolumab targeted at lupus.
In fiscal 2019, AstraZeneca expects several regulatory decisions, submissions, and clinical program advancements for indications in lung cancer, head and neck cancer, small-cell lung cancer, bladder cancer, type 2 diabetes, and anemia.
In fiscal 2019, AstraZeneca expects a regulatory decision in the European Union for Lynparza as an indication in breast cancer, and a regulatory submission for Lynparza for pancreatic cancer.
The company expects several developments for Imfinzi in fiscal 2019. A data readout is expected from the drug’s PACIFIC, NEPTUNE, and POSEIDON trials for lung cancer. Additionally, a regulatory submission is expected for Imfinzi as a first-line treatment for head and neck cancer. Data readouts and regulatory submissions are expected for Imfinzi as indications in small cell lung cancer and bladder cancer as well.
In fiscal 2019, a regulatory submission is expected for Calquence for chronic lymphocytic leukemia, Brilinta for coronary artery disease, and Farxiga for type 2 diabetes.