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US, EU regulators start review of Roche’s Soliris rival satralizumab

Sets up a possible market clash with Alexion next year

Roche

The FDA and EMA have kicked off their reviews of Roche’s satralizumab for rare disease neuromyelitis optica spectrum disorder (NMOSD), setting up a possible market clash with Alexion’s Soliris next year.

NMOSD is an autoimmune disease of the central nervous system – often misdiagnosed as multiple sclerosis – that is characterised by progressive damage to neurons during relapses that can lead to blindness and paralysis.

At the moment the only approved treatment in the US is Alexion’s complement C5 inhibitor Soliris (eculizumab), which got a green light from the FDA in June, and there are no licensed drugs to treat the disease in Europe.

Interleukin-6-targeting antibody satralizumab has been filed for approval based on two phase 3 trials which show that it can reduce relapses in NMOSD patients.

In the SAkuraStar trial reported at the ECTRIMS conference in Stockholm, Sweden, last month, the antibody reduced the risk of relapse in NMOSD patients by 55% compared to placebo. Similarly, the earlier SAkuraSky study showed a 62% reduction in the risk of relapses versus control.

The drug performed even better in patients with a biomarker for NMOSD – anti-aquaporin-4 (AQP4) antibody – with a 74% reduction in relapse risk in SAkuraStar and a 79% fall in SAkuraSky.

With all the usual caveats about comparing drugs without head-to-head trials, that seems to be a little higher than Soliris, which in trials reduced the risk of relapse by around 65% in AQP4-positive patients.

Anti-AQP4 antibodies – which are thought to damage specific nerve cells called astrocytes in the optic nerve, spinal cord and brain - can be detected in the blood of around two-thirds of NMOSD patients, according to Roche.

Soliris was approved by the FDA to treat AQP4-positive NMOSD, so if approved for its proposed indication satralizumab will have the advantage of being suitable for use in ‘all-comers’ with the disease – which could make it a better first-line option.

Meanwhile, another emerging rival in the NMOSD category is Viela Bio, whose inebilizumab was filed for approval with the FDA earlier this year. Viela thinks inebilizumab has a dosing advantage over both Soliris and satralizumab as it can be delivered just twice a year.

The complicating factor for both new drugs is that lower-cost biosimilars of Soliris could reach the market within the next coupled of years in the US and Europe – depending on the outcome of patent litigation.

Roche says NMOSD affects over 10,000 people in Europe, 15,000 people in the US and 'up to hundreds of thousands of people worldwide'.

Article by
Phil Taylor

30th October 2019

From: Regulatory

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