Drugs

Elements Removed from Sabril REMS

FDA says it has approved an sNDA modifying the Risk Evaluation Mitigation Strategy (REMS) for Lundbeck’s anticonvulsant Sabril (vigabatrin) by removing some REMS elements. An agency statement says that FDA determined that although the risk of vision loss with Sabril still exists, the REMS should be modified to remove certain elements.

The drug was originally approved with a REMS to ensure that its benefits outweigh the risks of vision loss and suicidal thoughts and behaviors, the notice says. Since approval, the REMS has required periodic visual monitoring results to be documented through submission of ophthalmic assessment forms (OAFs). The agency now says that requiring OAF submission as a REMS element is no longer necessary to ensure the Sabril benefits outweigh its risks. “Prescribers should continue to follow the vision monitoring recommendations as described in the prescribing information for Sabril,” the notice says.

The REMS also has been modified to remove additional educational requirements about the risk of suicidal thoughts and behaviors because thus risk is adequately communicated in the Warnings and Precautions section and the Medication Guide of the approved prescribing information. Also eliminated is the patient registry because the related postmarketing study, which is a postmarketing requirement, is a better mechanism for further characterizing and assessing the risk of vision loss associated with Sabril, FDA says.

A final modification will allow for inpatient pharmacy certification to alleviate delays in starting Sabril treatment and treatment interruptions during hospitalizations.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome