The European drug market could soon be poised to receive three new entries, as the European Committee for Healthcare and Medicinal Products (CHMP) has recommended drugs by Novartis, Arrowhead Pharmaceuticals and Sanofi for approval across the continent.
The first to announce a CHMP blessing for a drug in its pipeline today was Sanofi, which has received a positive opinion from the committee on its non-relapsing secondary progressive multiple sclerosis (nrSPMS) therapy, Cenrifki (tolebrutinib). The CHMP’s decision comes despite a setback in the US, where regulators declined to approve the drug amid concerns around its potential liver injury risks.
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The Bruton’s tyrosine kinase (BTK) inhibitor secured the CHMP’s blessing based on Phase III data from the HERCULES trial (NCT04411641), which found that Cenrifki prolonged the time to six-month confirmed disability progression by 31% over placebo. Following the CHMP’s verdict, the European Medicines Agency (EMA) will now decide whether to grant the drug an approval, which Sanofi expects “in the coming months.”
Cenrifki’s CHMP nod comes as similar safety issues continue to plague Roche’s MS candidate fenebrutinib – another BTK inhibitor being evaluated in MS.
MS specialists previously interviewed by Pharmaceutical Technology’s sister publication, Clinical Trials Arena, touted the strong uptake potential of BTK inhibitors in MS, but they noted that healthcare providers prescribing the drug will need to carefully monitor patients’ liver enzymes.
Arrowhead eyes Redemplo’s European debut
Next on the CHMP’s green list is Arrowhead’s rare disease therapy, Redemplo (plozasiran). While the drug has made a debut on the US market for patients with genetic fat breakdown disorder, familial chylomicronemiachylomicronaemia syndrome (FCS), it is yet to achieve this feat on the European market.
Arrowhead hopes to change this, though, with the EMA set to make a call on the drug’s market future based on the results of the Phase III PALISADE study (NCT05089084) in Q2 2026. During the trial, Redemplo diminished patient triglyceride levels by a median of 80% from baseline, resulting in a significant drop in acute pancreatitis cases versus placebo.
If approved, it would become the first and only siRNA therapy for FCS, breaking Ionis’ European dominance in this indication underpinned by Tryngolza (olezarsen) and its Akcea co-developed therapy, Waylivra (volanesorsen).
According to analysts at GlobalData, parent company of Pharmaceutical Technology, Redemplo has a blockbuster future, with a consensus forecast predicting the drug will bring in $1bn in 2032 – eclipsing the sales of both Waylivra and Tryngolza.
Novartis seeks larger slice of European SMA market
The third therapy to garner positive sentiments from the CHMP is Novartis spinal muscular atrophy (SMA) therapy, Itvisma (onasemnogene abeparvovec), which broke out on the US market in November 2025.
The committee issued its opinion based on the positive results of the Phase III STEER study (NCT05089656), which demonstrated Itvisma’s potential to significantly improve motor function over a 52-week period. According to Novartis, the one-time, survival motor neuron 1 (SMN1) gene-targeting replacement therapy could reduce a patient’s need for chronic SMA treatment – potentially lowering disease burden in those aged two or older.
If approved, Itvisma could bolster Novartis’ presence in the SMA market, which is currently defined by its blockbuster gene therapy, Zolgensma (onasemnogene abeparvovec). It would also become the first gene replacement therapy to secure the European regulatory greenlight in SMA, potentially offering new options over currently approved therapies like Zolgensma, Roche’s Evrysdi (risdiplam) and Biogen’s Spinraza (nusinersen).
Currently, Novartis’ compatriot, Roche, dominates the SMA market with Evrysdi (risdiplam), which took the crown as 2025’s best-selling drug in this indication. The therapy, which is available in both liquid and pill formats, became the first non-invasive treatment for SMA approved in Europe back in June 2025.
