--- title: 'Regulatory Daily Summary: What Happened on October 30, 2026' headline: UK lowers Casgevy’s minimum age to five, EU opens two safety reviews description: The MHRA expanded access for children with two inherited blood disorders. The EMA began reviews of neurological and psychiatric effects linked to Deanxit and allergic reactions tied to immunoglobulin batches. url: https://thebench.bio/news/regulatory/2026-10-30 topic: regulatory date: '2026-10-30' covers: - '2026-10-30' date_published: '2026-10-30T12:03:31Z' date_modified: '2026-10-30T12:03:31Z' tags: - Industry - Regulatory sources: 4 publisher: TheBench.Bio --- # Regulatory Daily Summary: What Happened on October 30, 2026 **UK lowers Casgevy’s minimum age to five, EU opens two safety reviews** The MHRA expanded access for children with two inherited blood disorders. The EMA began reviews of neurological and psychiatric effects linked to Deanxit and allergic reactions tied to immunoglobulin batches. ## Today in brief The MHRA extended UK authorization of Casgevy to eligible patients aged five and older with severe sickle cell disease or transfusion-dependent β-thalassemia, down from 12. [1] The EMA’s safety committee opened reviews of Deanxit after reports of serious neurological and psychiatric effects, and of human normal immunoglobulin medicines after clusters of allergic reactions. [2] ## 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 - 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] - 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] ## The day in numbers - **5 years**: Minimum age for eligible UK patients with severe sickle cell disease or transfusion-dependent β-thalassemia to receive Casgevy, down from 12. [1] - **2 reviews**: Safety reviews opened by the EMA committee: one for Deanxit and one covering human normal immunoglobulin medicines. [2] ## Sources 1. [MHRA approves gene-editing treatment for children aged five and over with serious inherited blood disorders](), MHRA, 2026-10-30 2. [Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026](), EMA Press, 2026-10-30 3. [DEA Clarifies Direct Delivery of Prescribed Controlled Substances to Practitioners](), FDA Law Blog, 2026-10-30 4. [Medtronic secures CE Mark for new cardiac pacing portfolio](), Pharmafile, 2026-10-30 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: