AstraZeneca says that regulators in the USA have accepted its file for Epanova, a heart drug derived from fish oils.
Specifically, the US Food and Drug Administration has accepted for review a New Drug Application for Epanova, a coated soft gelatin capsule containing a mixture of polyunsaturated free fatty acids derived from fish oils, for the treatment of patients with severe hypertriglyceridemia. The agency has given the treatment a Prescription Drug User Fee Act goal date of May 5 next year.
The NDA for Epanova was filed by Omthera Pharmaceuticals, now owned by AstraZeneca, in July 2013. The submission was based around two Phase III studies examining the effectiveness of the drug in lowering very high triglycerides and in reducing non-HDL cholesterol in combination with a statin. Both trials were conducted under a special protocol assessment with the FDA.
If approved, Epanova will go up against fish oil drugs which are already available, GlaxoSmithKline's Lovaza and Amarin’s Vascepa. AstraZeneca has particularly high hopes for combination of the drug with its blockbuster lipid-lowerer Crestor (rosuvastatin).
Meantime, an AstraZeneca spokesperson has confirmed to PharmaTimes that it has filed naloxegol for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.
Naloxegol is a peripherally-acting mu-opioid receptor antagonist (PAMORA) was licensed from Nektar Therapeutics in September 2009. Under the terms of the agreement, the latter will receive a $70 million milestone payment once the NDA is accepted by the FDA.
In August, AstraZeneca also filed naloxegol with the European Medicines Agency, which could trigger another $25 million payment to Nektar, if accepted.