16th Oct 2018 07:55
LONDON (Alliance News) - AstraZeneca PLC on Tuesday said the US Food & Drug Administration has granted orphan drug designation to Lynparza for the treatment of pancreatic cancer.
Pancreatic cancer accounts for only 3% of all cancers in the US and is often diagnosed late, with survival rates for the disease at just 8.5%.
Orphan drug status is granted in the US for medicines intended to treat disorders affecting fewer than 200,000 people, and is intended to streamline the approvals process for these drugs. It also grants a longer period of market exclusivity.
The use of Lynparza in the treatment of pancreatic cancer is currently being assessed via a phase three randomised placebo-controlled trial of the drug in 145 patients. Results from this trial are expected in the first half of 2019.
Related Shares:
Astrazeneca