EMA accepts AstraZeneca’s naloxegol marketing authorisation application

AstraZeneca today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation (OIC) for adult patients 18 years and older, including patients with inadequate response to laxatives.

The MAA filing was based on comprehensive data from the core Phase III KODIAC programme, comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of OIC. Two pivotal Phase III studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week, multicentre, randomised, double blind, placebo-controlled trials, evaluated 12.5 mg and 25 mg doses of naloxegol administered once-daily. KODIAC-07 was a 12-week safety extension of KODIAC-04, and KODIAC-08 (n= 534) was an open-label, randomised, 52-week, long-term safety trial.

Naloxegol has the potential to be the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for patients with OIC. Naloxegol was developed using Nektar’s oral small molecule polymer conjugate technology.

Naloxegol is covered by the exclusive worldwide license agreement announced on 21 September 2009 between AstraZeneca and Nektar Therapeutics. Under the terms of the recently amended license agreement, AstraZeneca will make a $25 million milestone payment to Nektar within five business days of acceptance of the MAA by the EMA.