Regulatory Daily Summary: What Happened on October 30, 2026

UK extends Casgevy authorization to children aged five and older

The Medicines and Healthcare products Regulatory Agency extended Casgevy’s UK authorization to eligible patients aged five and older with severe sickle cell disease or transfusion-dependent β-thalassemia.1 The treatment was previously authorized for patients aged 12 and older. The extension was granted on October 29.1

Casgevy edits a gene in a patient’s bone marrow stem cells. The cells are collected, modified in a laboratory, then infused after conditioning treatment.1 The MHRA said its decision followed an assessment of safety, quality, and effectiveness evidence. The agency will continue monitoring the treatment.1 Reported side effects include nausea, fatigue, fever, and increased infection risk. Patients may need to stay in hospital after infusion while the modified cells settle in the marrow.1

EU safety committee reviews Deanxit and immunoglobulin medicines

The EMA’s Pharmacovigilance Risk Assessment Committee opened a review of Deanxit, a fixed-dose treatment for depression and anxiety, after reports of serious neurological and psychiatric effects.2 Reported effects included movement problems and difficulties with memory or thinking. In some cases, symptoms continued after treatment ended.2

The committee also began reviewing human normal immunoglobulin medicines after increased reports of allergic reactions linked to particular batches.2 Reported reactions ranged from rash and itching to anaphylaxis and angioedema. Clusters prompted precautionary recalls and withdrawal of affected batches in some EU countries.2 Investigations have not established the cause of the clusters or whether other immunoglobulin medicines could be affected.2 The review covers medicines administered intravenously, under the skin, or into muscle. The committee will seek information from manufacturers and consider whether additional risk-reduction steps are needed.2

Also worth knowing

• F

  On October 28, the DEA issued optional, nonbinding guidance allowing pharmacies to deliver eligible controlled-substance prescriptions to a practitioner designated by the patient through a state-compliant power of attorney, for administration to that patient.3

• P

  Medtronic received CE Mark approval for five Vitalis pacemakers, including devices offering conduction system pacing, which uses the heart’s electrical pathways to coordinate ventricular contractions.4