Roche ENSPRYNG approved by the European Commission as the first

  • ENSPRYNG is the first and only treatment approved for adults and adolescents in the EU with AQP4-IgG seropositive NMOSD
  • ENSPRYNG can be used as monotherapy or in combination with immunosuppressive therapy to reduce relapses and prevent permanent disability
  • In phase III studies, ENSPRYNG significantly reduced the number and severity of relapses in people with AQP4-IgG seropositive NMOSD

Basel, June 28, 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved ENSPRYNG® (satralizumab) for the treatment of adults and adolescents from 12 years of age years with seropositive neuromyelitis optic (NMOSD) spectrum disorder aquaporin-4 (AQP4-IgG) antibody, as monotherapy or in combination with immunosuppressive therapy (STI). ENSPRYNG is the first and only NMOSD treatment administered subcutaneously every four weeks, allowing home administration after proper training.

“An NMOSD relapse can be devastating, causing permanent neurological damage and disability that accumulates with subsequent relapses, which is why our goal is to prevent them,” said Professor Dr Friedemann Paul, professor of clinical neuroimmunology at the Charité Universitätsmedizin Berlin. “With the approval of ENSPRYNG, we now have a treatment option with a favorable safety profile that dramatically reduces relapses in AQP4-IgG seropositive adults and adolescents after their first NMOSD crisis or in more advanced disease. , either as monotherapy or in combination with STI. It is important to note that people with NMOSD now have the option of providing treatment at home, which may reduce the need to travel for hospital appointments.

The EC approval is supported by the results of two Phase III studies, in which ENSPRYNG has shown robust and sustained efficacy in reducing the risk of relapse in people with AQP4-IgG seropositive NMOSD. AQP4-IgG are present in about 70-80% of people with NMOSD, who tend to have a more severe disease course than those who do not express AQP4-IgG antibodies.

“We thank the NMOSD community for their partnership and are delighted that ENSPRYNG is available to people in the EU who until now had limited and accessible treatment options,” said Levi Garraway, MD, Ph .D., Medical Director and Head of Global Product Development. “Building on our growing scientific understanding of neuroimmunological conditions, we are confident that ENSPRYNG can transform the way people with NMOSD are treated by integrating into their daily lives. “

ENSPRYNG is the first and only drug approved for NMOSD in the EU designed to bind to and block the interleukin-6 (IL-6) receptor, a central driver of inflammation associated with NMOSD . The treatment was designed by Chugai, a member of the Roche group, using novel antibody recycling technology. Compared to conventional antibodies, ENSPRYNG’s recycling antibody technology allows the drug to stay in the bloodstream for a longer period of time and repeatedly bind to its target (the IL-6 receptor) – maintaining maximum IL-6 suppression in a chronic disease such as NMOSD and allowing subcutaneous dosing every four weeks.

Roche is working closely with reimbursement and health technology assessment organizations in EU member states to provide access to ENSPRYNG to those who may benefit from this treatment option as soon as possible.

About SakuraStar and SakuraSky in NMOSD
ENSPRYNG was the subject of two pivotal phase III studies in neuromyelitis optic spectrum disorders (NMOSD), the primary endpoint of both studies being the time to first relapse defined by the protocol (PDR ) assessed by an independent review committee during the double-blind period.

The phase III study SAkuraStar evaluated the efficacy and safety of ENSPRYNG monotherapy administered to adults with NMOSD. In the anti-aquaporin-4 (AQP4-IgG) seropositive subgroup, 83% of patients treated with ENSPRYNG did not relapse at 48 weeks, compared with 55% of patients treated with placebo. At 96 weeks, 77% of people treated with ENSPRYNG had not relapsed, compared to 41% on placebo.

The SakuraSky phase III study evaluated the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. Overall, 92% of AQP4-IgG seropositive participants receiving ENSPRYNG in combination with IST remained relapse-free at 48 and 96 weeks, compared with 60% and 53% with placebo, respectively.

ENSPRYNG has shown a favorable safety and tolerability profile in phase III studies. The most frequently observed adverse reactions in the tolerant population were: headache, arthralgia, decrease in the number of white blood cells, hyperlipidaemia and injection-related reactions.

About neuromyelitis optical spectrum disorder (NMOSD)
NMOSD is a rare, permanent, debilitating autoimmune disease of the central nervous system that primarily damages the optic nerve (s) and spinal cord, causing permanent blindness, muscle weakness and paralysis. People with NMOSD experience unpredictable and severe relapses that directly cause cumulative and permanent neurological damage and disability. In some cases, relapse can lead to death. NMOSD affects more than 10,000 people in Europe, up to 15,000 people in the United States and approximately 200,000 people worldwide. NMOSD can affect people of any age, race, and gender, but it is more common in women in their 30s and 40s, and appears to occur at higher rates in people of African or Asian descent.

NMOSD is usually associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes, resulting in inflammatory damage to the optic nerve (s), spinal cord and brain. AQP4-IgG antibodies are detectable in the blood serum of approximately 70-80% of people with NMOSD.

Although most cases of NMOSD can be confirmed with diagnostic tests, people living with the disease are still frequently misdiagnosed with multiple sclerosis. This is due to the overlap in characteristics of the two disorders, including a higher prevalence in women, similar symptoms, and the fact that people can relapse under both conditions.

About ENSPRYNG® (satralizumab)
ENSPRYNG, which was designed by Chugai, a member of the Roche group, is a humanized monoclonal antibody that targets the activity of interleukin-6 (IL-6) receptors. The IL-6 cytokine is believed to be a key factor in NMOSD pathological processes, triggering the inflammatory cascade and leading to damage and disability. ENSPRYNG was designed using new recycling antibody technology. Compared to conventional antibodies, ENSPRYNG’s recycling antibody technology allows the drug to stay in the bloodstream longer and repeatedly bind to its target (the IL-6 receptor) – maintaining maximum suppression IL-6 in a chronic disease such as NMOSD and allowing subcutaneous dosing every four weeks.

Positive Phase III results for ENSPRYNG, both as monotherapy and in combination with baseline immunosuppressive therapy, suggest that inhibition of IL-6 is an effective therapeutic approach for NMOSD. The phase III clinical development program for ENSPRYNG included two studies: SakuraStar and SakuraSky.

ENSPRYNG is currently approved in 54 countries, including the United States, Canada, Japan, China and countries within the EMA territory.

ENSPRYNG has been designated as an orphan drug in the United States, Europe and Japan. In addition, the FDA granted it the Breakthrough Therapy designation for the treatment of NMOSD in December 2018, which is granted to treatments that can demonstrate substantial improvement over other available options.

About Roche in neuroscience
Neurosciences are a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is studying more than a dozen drugs for neurological disorders, including multiple sclerosis, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorders. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Roche is a global pharmaceutical and diagnostics pioneer focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, along with growing capabilities in data-driven medical knowledge, help Roche deliver truly personalized healthcare. Roche works with partners in the healthcare industry to provide the best care for every person.

Roche is the world’s largest biotechnology company, with truly differentiated drugs in oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is also the world leader in in vitro diagnostics and tissue diagnostics for cancer, and a pioneer in the management of diabetes. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry leading partner for medical knowledge.

Founded in 1896, Roche continues to research better ways to prevent, diagnose and treat disease and make a lasting contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty drugs developed by Roche are included in the World Health Organization’s Model Lists of Essential Medicines, including life-saving antibiotics, antimalarials and cancer drugs. In addition, for the twelfth year in a row, Roche has been recognized as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI).

The Roche group, headquartered in Basel, Switzerland, is active in more than 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and achieved sales of CHF 58.3 billion. Genentech, in the United States, is a full member of the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical, in Japan. For more information, please visit www.roche.com.
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  • 28062021_MR_Enspryng CE approval


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