AstraZeneca PLC’s (LON:AZN) Lynparza pancreatic cancer treatment has been granted orphan drug designation by the US Food and Drug Administration.
Lynparza was previously granted ODD by regulators back in 2013 for use in ovarian cancer patients.
Its use in pancreatic cancer is being assessed in the ongoing phase III POLO trial results from which are due early next year.
READ: AstraZeneca drug successfully negotiates final-stage trial
“Pancreatic cancer is a relatively less common, but life-threatening, form of cancer,” said Astra’s head of global clinical development Roy Baynes.
“The FDA granting orphan drug designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need.”
Orphan drug status gives drugmakers – in this case, Astra and its partner, Merck – certain benefits in order to encourage them to develop treatments for rare diseases which might otherwise lack sufficient profit motive.
For example, it can be easier to gain marketing approval for that drug or extend the exclusivity periods, while there are often also financial advantages such as tax breaks and R&D grants.
Without these incentives, companies might not pursue a drug’s development because the R&D costs would be too expensive.
Shares rose 0.6% to 5,653p on Tuesday Morning.