US FDA accepts AstraZeneca’s NDA for naloxegol
The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) from Anglo-Swedish drug major AstraZeneca (LSE: ANZ), the company revealed this morning.
Naloxegol is part of the exclusive worldwide license agreement announced in 2009, between AstraZeneca and Nektar Therapeutics (Nasdaq: NKTR). Under the terms of the amended license agreement, AstraZeneca will make a $70 million milestone payment to Nektar within five business days of acceptance of the NDA by the FDA.
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