dm+d

Unassigned

New Medicines

Enspryng Neuromyelitis optica (NMO) - monotherapy or add-on to immunosuppressive therapy, in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive

Information

Enspryng
New molecular entity
Roche
Genentech (Roche)

Development and Regulatory status

Phase III Clinical Trials
Approved (Licensed)
Launched
Yes
Yes
Sep 21Roche has no current plans to make satralizumab available in the UK [25].
Jun 21Approved in EU [24].
Apr 21 Recommended for EU approval by CHMP - the full indication is "as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive (see section 5.1)." Enspryng will be available as a solution for injection (120 mg/mL) in prefilled syringes [21].
Jan 21Satralizumab is still under evaluation by the EMA [20]
Aug 20Enspryng (satralizumab-mwge) approved by FDA as a s.c. treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). [18]
Jul 20Has orphan drug status in US [16].
Nov 19The EMA has granted satralizumab accelerated assessment [13].
Oct 19Has also been filed in the US [12].
Sep 19Filed in EU under centralised procedure. Application is being reviewed under the EMA accelerated assessment programme [11].
Dec 18Assigned FDA Breakthrough Therapy Designation for neuromyelitis optica and neuromyelitis optica spectrum disorders [9].
Dec 17Filings now expected 2019 [6].
Mar 17EU & US filings planned 2018 [5].
Oct 16Has orphan drug status for NMO in EU [4].
Mar 16In PIII development [1].

Category

Anti-IL-6 receptor humanised monoclonal antibody
Neuromyelitis Optica is a rare disorder affecting eyes and spinal cord leading loss of vision, mobility, and sensation. 90% of patients have relapsing NMO. It affects about 0.4 in 10,000 people in the EU equivalent to a total of around 20,000 people.
Neuromyelitis optica (NMO) - monotherapy or add-on to immunosuppressive therapy, in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive
Subcutaneous

Further information

Yes

Trial or other data

Jun 21Efficacy and safety results of satralizumab in adults with AQP4-IgG seropositive NMOSD announced which showed that satralizumab significantly reduced the risk of relapse (defined as new or worsening symptoms); by 78% in SAkuraSky and 74% in SAkuraStar (the extended study) vs. placebo. Overall rates of adverse events were comparable between the placebo and satralizumab groups. However, infections were more common with satralizumab and included nasopharyngitis, upper respiratory track infections, nasopharyngitis and cellulitis. [23]
Mar 21The company informs NICE that it will not provide an evidence submission for an appraisal. NICE will consider next steps [22].
Jul 20PIII Sakura Star has been published in Lancet Neurology 2020; 19(5): 402-12 [19].
Jul 20Safety data pooled from two PIII trials have been released. Satralizumab patients experienced 15 serious adverse events (SAEs) per 100 patient years, compared to 18 SAEs experienced by placebo patients. UTIs and URTIs were the most common adverse events across both treatment groups. No anaphylactic reaction was experienced. [17].
Apr 20PIII NCT02073279 (n=168) found that this monoclonal antibody targeting IL6 reduced rate of relapse vs. placebo in overall trial population (protocol-defined relapses in 19 [30%] on satralizumab and 16 [50%] on placebo; HR 0.45, 95% CI 0.23–0.89; p=0.018), with a favourable safety profile [15].
Nov 19Results of PIII NCT02028884 (n=83) are published in the NEJM; it found that addition of satralizumab to immunosuppressant treatment led to a lower risk of relapse than placebo (20 vs. 43%, HR 0.38; 95% CI, 0.16-0.88), but did not differ from placebo in its effect on pain or fatigue, or in rates of serious adverse events/infections [14].
Sep 19Chugai report positive results from second PIII SAkuraStar (NCT02073279) study; results show a statistically significant reduction in risk of relapse by 55% vs. placebo (HR 0.45; 95% CI 0.23-0.89, p=0.0184). Global regulatory filings for treatment of NMOSD are planned this year [10].
Dec 18Results from the PIII global (incl US, Asia, EU, UK) SAkuraSky study (NCT02028884) found that satralizumab in addition to immunosuppressive therapy significantly reduced the risk of relapse in NMOSD by 62% (hazard ratio = 0.38 [95% confidence interval: 0.16-0.88], p=0.0184 [stratified log-rank test]). Patients who were relapse free at weeks 48 and 96 were 88.9% and 77.6% with satralizumab and 66.0% and 58.7% with placebo, respectively [7,8].
Mar 16Chugai expects that SA237 will have a similar safety and efficacy profile to tocilizumab, but with improved pharmacokinetic properties allowing for less frequent dosing. SA237 has been shown to continuously block IL-6 receptors over four times longer than tocilizumab. SA237 is expected to provide the convenience of subcutaneous administration at a dosing interval of longer than once-monthly [3].
Aug 14PIII (NCT02073279) study to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of SA237 as monotherapy in patients with NMO and NMOSD starts. 70 patients will be recruited in the US, Canada & Puerto Rico. Primary outcome is time to first relapse; collection of these data should complete Nov 16 [2].
Feb 14PIII (NCT02028884) study to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMO spectrum disorder (NMOSD) starts. 70 patients will be recruited in Japan. Primary outcome is time to first relapse; collection of these data should complete Aug 16 [2].

Evidence based evaluations