Roche clears EMA hurdle for 'satralizumab'
Roche Holding AG
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07:46 20/03/24
Roche announced on Wednesday that the European Medicines Agency (EMA) has validated its marketing authorisation application for ‘satralizumab’, for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it ‘accelerated assessment’.
The Swiss pharmaceutical giant said the validation confirmed that the submission was complete, and signified the application was now under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
It said the US Food and Drug Administration (FDA) also accepted the company’s biologics license application for satralizumab, with both the CHMP recommendation and the FDA decision expected in 2020.
“People living with NMOSD experience unpredictable relapses that can cause permanent neurological damage, and although there have been significant strides recently in understanding the disease, more approved options are needed with different treatment approaches. Satralizumab has shown robust efficacy sustained for 96 weeks and significantly reduced the risk of relapse across a broad patient population, while offering self-administered subcutaneous dosing every four weeks,” said Roche’s chief medical officer and head of global product development Levi Garraway.
“The FDA and EMA’s acceptance of the satralizumab applications bring us one step closer to providing a new medicine to thousands of people impacted by NMOSD, and we are working with the health authorities to make satralizumab available as soon as possible.”
Roche explained that accelerated assessment would reduce the timeframe for the EMA and CHMP to review the marketing authorisation, signifying the treatment was of “major interest” for public health or therapeutic innovation.
The FDA previously granted breakthrough therapy designation to satralizumab for the treatment of NMOSD last December.
In addition, satralizumab was granted priority review in Canada and Switzerland, and designated as an orphan drug in the US, Europe and Japan.
If the EMA’s CHMP adopts a positive opinion that is endorsed by the European Commission, satralizumab would be granted a marketing authorisation valid in all 28 member states of the European Union.
The satralizumab applications were based on positive results from two phase 3 studies - ‘SAkuraStar’ and ‘SAkuraSky’ - which evaluated the efficacy and safety of satralizumab as a monotherapy, and in combination with baseline immunosuppressant therapy, respectively.
In the SAkuraStar study, satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall study population of aquaporin-4 antibody (AQP4-IgG) seropositive and seronegative patients.
Satralizumab achieved a 74% reduction in the larger subgroup of AQP4-IgG seropositive patients, who the company said tended to experience a more severe disease course.
In the overall satralizumab-treated population, 76.1% were relapse-free at 48 weeks, and 72.1% relapse-free at 96 weeks, compared to 61.9% and 51.2% with placebo, respectively.
Data from the AQP4-IgG seropositive subgroup showed that 82.9% were relapse-free at 48 weeks and 76.5% relapse-free at 96 weeks when treated with satralizumab, compared to 55.4% and 41.1% with placebo, respectively.
Additionally, Roche said the the SAkuraSky study data showed a 62% reduction in the risk of relapses compared to placebo in the overall study population when used in combination with baseline immunosuppressant therapy, and a 79% reduction in the risk of relapses in AQP4-IgG seropositive patients.
In the overall satralizumab-treated population, 88.9% were relapse-free at 48 weeks, and 77.6% were relapse-free at 96 weeks, compared to 66.0% and 58.7% with placebo, respectively.
Data from the AQP4-IgG seropositive subgroup showed that 91.5% were relapse-free at 48 and 96 weeks when treated with satralizumab, compared to 59.9% and 53.3% with placebo, respectively.
Overall, the proportion of patients with serious adverse events was similar between the satralizumab and placebo treatment groups in both studies, Roche explained.
It said a lower rate of infections, including serious infections, was observed in patients treated with satralizumab compared with the placebo group.
Most adverse events were said to have been mild to moderate, with the most common adverse events in the satralizumab group being urinary tract infection and upper respiratory tract infection in the SAkuraStar study and upper respiratory tract infection, nasopharyngitis - the common cold - and headache in the SAkuraSky study.
As at 1243 CET, shares in Roche Holding were up 0.44% in Zurich, at CHF 295.95.