The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new subcutaneous (SC) formulation for Biogen’s multiple sclerosis treatment Tysabri.
The MHRA authorisation comes following the European Commission’s (EC) decision to approve the SC Tysabri (natalizumab) formulation in March, meaning the new administration route is approved in the UK and Ireland.
The approval of the SC formulation of Tysabri is based on data from the Phase 1 DELIVER and Phase II REFINE studies.
In these studies, the SC formulation of Tysabri 300mg demonstrated comparability to the intravenous (IV) 300mg administration of the therapy in efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profiles.
The safety of the SC formulation in both studies was generally consistent with the established benefit-risk profile of Tysabri IV in other clinical studies and the post-marketing setting, with the exception of injection site pain which can occur with SC injections.
“This unprecedented year has put the NHS under significant resource pressures and created new challenges for those living with long-term conditions, like MS, when accessing vital, life impacting treatments,” said Dr Mihaela Vlaicu, head of medical affairs UK and Ireland, Biogen UK and Ireland.
“Reinforced by nearly 15 years of real-world evidence and post marketing experience with natalizumab IV, SC offers a new method of delivery that can help to reduce patient time in a hospital setting and increase convenience in clinical practice,” she added.
In the UK, Tysabri is an authorised treatment for adults living with highly active relapsing-remitting multiple sclerosis.