TGA greenlights Sanofi’s first-in-class therapy in multiple sclerosis

Sanofi has secured Therapeutic Goods Administration (TGA) approval for its new class of oral Bruton’s tyrosine kinase inhibitor (BTKi), Cenrifki (tolebrutinib), for patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).

nrSPMS is characterised by a gradual worsening of disability without the clear relapses or attacks seen in earlier stages of multiple sclerosis. Managing this progression remains one of the most significant unmet needs in MS care, with patients often experiencing increasing disability, complex symptoms and declining independence despite the absence of active relapses.

“Most MS treatments target inflammatory activity associated with relapses, but in non-relapsing secondary progressive MS, disability worsens even after relapses stop. Cenrifki (tolebrutinib) acts on immune targets behind the blood-brain barrier thought to contribute to neuroinflammation and disease progression,” said Dr John Parratt, Consultant Neurologist, Royal North Shore Hospital and Director of Royal North Shore Hospital MS Clinic.

The TGA decision was supported by data from the Phase 3 HERCULES trial, which demonstrated a statistically significant and clinically meaningful 31% reduction in six-month confirmed disability progression compared with placebo in patients with relapse-independent progression.

The approval comes nearly three decades after the first therapies for relapsing-remitting MS entered the market, yet treatment options for nrSPMS remain sparse. Novartis’ Mayzent (siponimod), which received PBS listing for this patient cohort in November 2020, has been among the few therapies available for this patient cohort.

“The TGA approval of Cenrifki represents an important step forward in the treatment landscape for patients who have, to this point, had limited therapeutic options,” Dr Parratt added.

Rohan Greenland, CEO of MS Australia, said “For people living with non-relapsing secondary progressive MS, a lack of effective treatment can mean steadily increasing disability that is difficult to predict and manage. This can make it harder to stay in work, maintain independence and plan for the future, with significant impacts on day-to-day life.”

Sanofi has indicated it will now focus on securing reimbursement access for eligible patients through the Pharmaceutical Benefits Scheme (PBS). However, market access timelines remain a challenge, with the average time of 712 days between TGA approval and PBS listing, according to Amgen’s latest Patient Access Gap Tracker.

“The possibility of slowing disability progression associated with nrSMPS with a BTK inhibitor may help the people across Australia with this condition, as well as their carers and the broader healthcare system. Sanofi will continue to work with all stakeholders with the aim to make Cenrifki available for eligible nrSPMS patients in Australia,” said Liz Selby, Country Lead, Sanofi Australia and New Zealand.

Beyond nrSPMS, Cenrifki has also been investigated in other MS subtypes. In the Phase 3 PERSEUS trial in primary progressive MS (PPMS), however, the therapy did not meet its primary endpoint of significantly delaying disability progression.

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