MHRA and EC Grant Marketing Authorization for Biogen’s MS Treatment

Biogen UK has announced, in an April 15, 2021 press release, that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).

Both regulatory bodies’ approvals mean that adults patients living with highly active relapsing-remitting multiple sclerosis (MS) across the European Union (EU), in the United Kingdom, and Ireland now have access to natalizumab SC. Data from the DELIVER (Phase I) and REFINE (Phase II) trials were used in the regulatory review processes. In the clinical trials, the efficacy and safety of the SC formulation of natalizumab were found to be generally consistent with the intravenous (IV) formulation.

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

Similarly, as with the IV formulation, the SC formulation of natalizumab is administered once every four weeks by a healthcare professional in a clinical setting. The nature of the SC route of administration means that the clinical setting for the new formulation of natalizumab can be expanded out beyond clinical centers, allowing for the potential of care closer to home.

“This unprecedented year has put the NHS [National Health Service] under significant resource pressures and created new challenges for those living with long-term conditions, like MS, when accessing vital, life impacting treatments,” added Dr Mihaela Vlaicu, head of Medical Affairs UK and Ireland, Biogen UK and Ireland, in the press release. “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.”

Source: Biogen UK