Remedy Pharmaceuticals has announced that the US Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted orphan drug designation to its stroke drug Cirara for the treatment of large-territory acute ischaemic stroke—which includes large hemispheric infarctions (LHI).
As detailed by a Remedy press release, LHI is a particularly severe form of ischaemic stroke caused by a blockage in one of two large blood vessels in the brain—the internal carotid artery (ICA) or middle cerebral artery (MCA)—cutting off the blood supply to large areas of the brain, and resulting in severe swelling, significant mortality and high disability rates.
“The orphan drug designation for Cirara underscores the uniqueness of large-territory ischaemic strokes in terms of mechanism and universally poor outcomes in contrast to smaller strokes,” said Sven Jacobson, chief executive officer of Remedy. “This designation will accelerate our efforts to bring Cirara to acute ischaemic stroke patients at the highest risk of severe disability and death.”
The US FDA’s orphan drug designation programme provides orphan status to drugs or biologics intended to treat diseases or conditions that affect fewer than 200,000 people in the USA. Sponsors of medicines with orphan drug designation may be eligible for various incentives, including tax credits for qualified clinical trials, prescription drug user fee exemptions, and seven years of marketing exclusivity upon FDA approval, as noted in Remedy’s recent release.
