Pharmaceutical Market Europe • November 2025 • 7
NEWS
Novartis reports positive phase 3 results for Cosentyx
Novartis has announced that its treatment for polymyalgia rheumatica (PMR), Cosentyx (secukinumab), achieved all primary and secondary endpoints in the phase 3 REPLENISH trial.
REPLENISH is a global, multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 study evaluating the safety and efficacy of Cosentyx in patients with PMR. Participants across 27 countries were assigned to one of three treatment arms – Cosentyx 150 mg, Cosentyx 300 mg, or placebo – in combination with a 24-week steroid tapering regimen.
At Week 52, Novartis reported that Cosentyx – an interleukin-17A (IL-17A) inhibitor already approved for several inflammatory conditions, including psoriatic arthritis – met its primary endpoint, demonstrating statistically significant and clinically meaningful sustained remission compared with placebo.
All secondary endpoints were also met, including the proportion of patients achieving complete sustained remission at Week 52, the adjusted annual cumulative corticosteroid dose and the time to first use of escape or rescue therapy.
Novartis plans to present the full data at an upcoming medical congress and submit findings to health authorities in early 2026.
Genentech announces positive results for MS treatment
Genentech, a member of the Roche Group, has announced positive results from the first of two phase 3 trials investigating fenebrutinib, the first and only Bruton’s tyrosine kinase (BTK) inhibitor in development for the treatment of relapsing multiple sclerosis (RMS).
Multiple sclerosis (MS) is a chronic neurological condition affecting more than 2.9 million people globally. Approximately 85% of patients are diagnosed with RMS, which is characterised by relapses and progressive disability over time. The remaining 15% have primary progressive multiple sclerosis (PPMS), a form marked by continuous worsening of symptoms without relapses or remissions. Currently, the only treatment approved by the US Food and Drug Administration (FDA) for PPMS is Ocrevus (ocrelizumab).
Fenebrutinib is an investigational, oral BTK inhibitor that targets both B cells and microglia in the immune system. This dual mechanism of action is designed to address key drivers of MS pathology: B-cell inhibition helps to control the acute inflammation responsible for relapses, while targeting microglia within the central nervous system may limit chronic damage and slow long-term disability progression.
According to Genentech, fenebrutinib’s high potency, selectivity and reversibility are driven by its non-covalent binding properties, distinguishing it from other treatments currently in development.
Biogen and Eisai’s Alzheimer’s drug gets MHRA approval for updated dosing
Biogen and Eisai have received approval from the UK’s MHRA for an updated dosing regimen for their jointly-developed Alzheimer’s disease drug, LEQEMBI (lecanemab).
The latest approval allows for an intravenous (IV) maintenance dose to be administered every four weeks.
The MHRA first authorised LEQEMBI in August 2024 for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in adult patients who meet specific diagnostic criteria.
Alzheimer’s disease is a progressive neurodegenerative disease characterised by the formation of plaques – protein deposits made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein – in the brain. In the UK, estimates suggest that around 982,000 people are living with dementia, with Alzheimer’s disease being the cause in 60-70% of cases. These figures are expected to rise as the population ages.
The initial LEQEMBI dosing regimen is currently approved in 51 countries and remains under review in a further nine. The monthly maintenance dose has now been approved in the US, China and the UK, with regulatory submissions under consideration in four additional countries and regions.