GlaxoSmithKline Suffers Another Regulatory Setback
US Food and Drug Administration regulators announced on Friday that it will take three months longer than expected to decide whether Entereg, a treatment for post-operative ileus being co-developed by GlaxoSmithKline, will receive marketing approval. The drug was originally supposed to be reviewed for an up-or-down decision on Feb. 10.
Entereg is being co-developed with Pennsylvania-based Adolor Corporation. Post-operative ileus affects patients after bowel surgery. Symptoms include constipation and other gastrointestinal dysfunction.
An FDA advisory panel recommended approval in January but said Adolor needed to come up with a better plan to manage long term use of the drug. FDA regulators are concerned about safety data showing that long term use of Entereg can have adverse cardiovascular effects.
Adolor has submitted a new risk-management plan to the FDA, which will take the extra three months to review it. GlaxoSmithKline will split the revenue from any U.S. sales of Entereg with Adolor and is responsible for commercialization of the drug outside the country.
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