Drugs

Covid-19 Actemra REMS Guidance

FDA has published an immediately effective guidance, Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the Covid-19 Public Health Emergency, communicating its temporary policy for certain REMS (risk evaluation and mitigation strategies) requirements for tocilizumab (Genentech’s Actemra) due to the shortage related to the Covid-19 public health emergency. The document will remain in effect for the duration of the Actemra shortage.

The guidance says the Actemra shortage was first posted on the agency drug shortage Web page 8/17. That month also, Genentech issued statements on the global tocilizumab shortage due to an unprecedented surge in worldwide demand and supply constraints driven by the Covid-19 public health emergency.

The guidance says the agency recognizes that adherence to the REMS requirement for immediate access to tocilizumab, specifically the requirement that before infusion of the CAR T cell immunotherapy to a patient, a minimum of two doses of tocilizumab are available on-site for each patient and are ready for immediate administration (within two hours), may not be feasible because of the current tocilizumab shortage.

For CAR T cell immunotherapies subject to these REMS, it says, FDA does not intend to object if healthcare providers prescribe, dispense, or administer these biological products when two doses of tocilizumab are not available, provided that all of four specified circumstances are present.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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