MHRA grants marketing authorisation for new formulation of Tysabri

pharmafile | April 16, 2021 | News story | Medical Communications MHRA 

Biogen UK has been granted marketing authorisation by the MHRA for a subcutaneous (SC) injection of Tysabri (natalizumab), for adults living with highly active relapsing-remitting multiple sclerosis (RRMS), following the decision from the European Commission on 30 March.

Natalizumab SC offers comparable efficacy and safety, and builds on the long-term data and established clinical benefits of the natalizumab intravenous (IV) formulation. It is also the only high-efficacy disease modifying therapy for RRMS that offers two routes of administration, allowing for more flexibility for both patients and healthcare professionals.

The SC and IV formulations of natalizumab are administered once every four weeks by a healthcare professional in a clinical setting. However, the new SC formulation expands the clinical setting beyond infusion centres potentially bringing care closer to home.

David Martin, CEO of the MS Trust, said: “People have such varied experiences of living with MS which is why patient choice is a key factor. This treatment option offers flexibility and minimises the time spent receiving treatment, while still providing continuity of care through access to MS healthcare teams.”

The approval of the SC route of administration for natalizumab is based on data from the DELIVER (Phase I) and REFINE (Phase II) studies. The SC formulation of natalizumab at 300mg has shown comparability to the Q4W IV administration of 300mg natalizumab in efficacy, pharmacokinetic and pharmacodynamic profiles.

Dr Mihaela Vlaicu, Head of Medical Affairs UK and Ireland, Biogen UK and Ireland, said: “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.

“As our healthcare and everyday environment evolves, we must continue to provide solutions to address capacity and resource concerns within the health service, whilst addressing patient needs.

“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.”

Kat Jenkins

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