Pharmaceutical Market Europe • May 2026 • 8
NEWS
MHRA authorises Biogen’s higher-dose Spinraza for SMA treatment
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Biogen for a higher-dose regimen of Spinraza (nusinersen) to treat 5q spinal muscular atrophy (SMA).
The updated regimen includes a more rapid loading phase for ‘treatment-naïve’ patients, with two 50mg doses given 14 days apart, followed by 28mg maintenance doses every four months. Patients transitioning from the existing 12mg regimen will receive a single 50mg dose before moving to the same maintenance schedule.
SMA is a rare genetic neuromuscular condition affecting around 1,600 people in the UK, with around 70 children born with the condition each year. The most common form, 5q SMA, which accounts for an estimated 95% of cases, is caused by changes in a gene responsible for producing survival motor neuron (SMN) protein. This leads to progressive muscle weakness and loss of movement.
The decision is supported by data from the phase 2/3 DEVOTE study and its long-term extension, which evaluated the higher-dose regimen in both treatment-naïve patients and those previously treated with the 12mg dose.
The higher-dose regimen is already approved in the US, EU, Switzerland and Japan.
European Commission approves RSV antibody for infants
The European Commission has approved Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
The long-acting monoclonal antibody is designed to provide protection for up to five months with a single dose and does not require weight-based dosing. The approval applies across all 27 EU states, dependent on reimbursement procedures completion, as well as Iceland, Liechtenstein and Norway.
RSV is a common seasonal virus that can lead to serious respiratory conditions, including bronchiolitis and pneumonia, and remains a leading cause of hospitalisation among infants worldwide.
The European decision is supported by results from the phase 2b/3 CLEVER trial and interim data from the phase 3 SMART trial, which assessed the safety and efficacy of Enflonsia in infants entering their first RSV season, including those at increased risk of severe disease.
Enflonsia is already approved in the US, Canada and Switzerland, with further regulatory submissions ongoing in other markets. The EU approval extends access to RSV prevention as health systems continue to address the impact of seasonal infections on infant health.
Grifols announces proof-of-concept data to identify early signs of Parkinson’s disease
Grifols has announced proof-of-concept data from its Chronos-PD programme, which uses AI, advanced proteomics and real-world data to identify early signs of Parkinson’s disease (PD).
The data demonstrates that individuals with PD experience biological changes over a decade before clinical diagnosis, allowing for potential early diagnosis and intervention in the future.
Affecting nearly one million people in the US and nearly six million worldwide, PD occurs when the brain cells that make dopamine stop working or die. Understanding of the causes of the disease remains limited despite decades of research and treatment advancement.
Funded by the Michael J. Fox Foundation for Parkinson’s Research (MJFF), the study is the most deeply profiled longitudinal proteomic study in PD to date, with over 2,600 longitudinal plasma samples and over 25,000 protein types analysed using four complementary proteomics platforms.
After analysing longitudinal plasma samples covering a period of up to 12 years before the diagnosis of PD and nine years afterwards in the pilot study, researchers were able to track the evolution of distinct plasma proteins in people with PD. This information has the potential to help establish an early-warning system for PD.