AstraZeneca’s Movantik Looks Clear After FDA Panel; Salix’ Relistor Looks Cloudy
Executive Summary
Naloxegol development program included long-term controlled trial, the advisory committee’s preferred approach for studying CV events with peripherally active mu opioid receptor antagonists for opioid-induced constipation, while methylnaltrexone may suffer from the lack of control arm in its long-term study.
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Naloxegol CV Safety Findings “Reassuring” – NEJM Study
AstraZeneca’s peripherally acting mu-opioid receptor antagonist was not associated with an increased incidence of major cardiovascular events in Phase III studies of chronic pain patients with opioid-induced constipation. An FDA advisory committee will review CV safety data for the drug class June 11-12.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.