The third innovative drug for optic neuroscolonitis spectrum disorder (NMOSD)! Roche IL-6R monoanti-anti-Enspryng is approved by the FDA!

!--, Aug. 16, 2020 / -- Roche recently announced that the U.S. Food and Drug Administration (FDA) has approved Ensralizumab for the treatment of adult patients with anti-water channel protein-4 (AQP4) antibody-positive visual neurone spinal cord spectrum disorder (NMOSD).
NMOSD is a rare, lifelong, debilitating autoimmune disease of the central nervous system, often misdiagnosed as multiple sclerosis (MM).
NMOSD mainly damages the optic nerve and spinal cord, leading to blindness, muscle weakness and paralysis.
It's worth noting that Enspryng is the first and only fdate-approved subsesteal treatment for AQP4 antibody-positive NMOSD, which can be injected every 4 weeks by the patient himself or his caregiver.
same time, Enspryng is the first and only treatment that targets the active treatment of NMOSD by inhibiting the activity of lecytocytoplein-6 subjects (IL-6R).
In two key Phase III studies, Enspryng, as a monotherapy and as an additional therapy for baseline immunosuppressant therapy (IST), showed strong efficacy in a wide range of NMOSD patient populations and significantly reduced the risk of recurrence.
has so far been approved in Japan, Canada and Switzerland, and is under review by a number of regulators, including the European Union and China.
in Japan, the United States, the European Union, satralizumab have been granted the orphan drug qualification (ODD), and in the United States was also awarded the breakthrough drug qualification (BTD).
NMOSD is usually associated with pathogenic antibodies (anti-AQP4 antibodies), which target and damage a specific cell called astrological glial cells, leading to inflammatory lesions in the optic nerve, spinal cord, and brain.
anti-AQP4 antibodies can be detected in the serum of about 70-80% of NMOSD patients, who tend to experience more severe illnesses.
most cases of NMOSD can be diagnosed through diagnostic testing, up to 30% of patients are often misdiagnosed as multiple sclerosis (MM).
Enspryng is a human-based monoclonal antibody that targets the binding of interlebines 6 subjects (IL-6R), il-6R is believed to play a key role in inflammation in patients with NMOSD.
the drug was developed by Roche's Chugai Pharma using a new antibody recovery technology.
compared to conventional techniques, this technique extends the duration of antibody circulation, maximizes the suppression of IL-6 signals, and minimizes the safety risk in chronic diseases.
patients with NMOSD experience unpredictable and severe relapses that directly lead to cumulative, irreversible nerve damage and disability.
prevention of recurrence through early treatment can have a positive impact on disability prevention, which is the primary goal of NMOSD disease management.
Roch's chief medical officer and head of global product development, Dr. Levi Garraway, said, "Today the FDA approved Enspryng, the first insulated NMOSD treatment using a new recycled antibody technology, building on our work with Ocrevus to treat multiple sclerosis, developing first-class drugs and further deepening scientific understanding of neuroimmune diseases."
we thank the NMOSD community, including patients and researchers involved in the Enspryng clinical trial.
"NMOSD" (Photo: empr.com) FDA approves Enspryng, based on positive results from one of the largest critical clinical trials for NMOSD.
data from two randomized controlled Phase III studies (SakuraStar, SAkuraSky) confirmed that enspryng was used as a monotherapy and baseline in adult patients with AQP4 antibody-positive NMOSD Immunosuppressant (IST, commonly used to manage relapse-related NMOSD symptoms) combined treatment has strong and long-lasting efficacy and good safety: Enspryng significantly reduces the risk of recurrence compared to placebos and lasts up to 96 weeks.
- SAkuraStar Study: Assessing the efficacy and safety of Enspryng monotherapy and placebo.
results showed that in the AQP4 antibody-positive subgroup, 76.5 percent of patients in the Enspryng treatment group did not relapse at week 96, and 41.1 percent in the placebo group.
- SAkuraSky Study: Assessed the efficacy and safety of Enspryng Joint Baseline IST and Placebo Joint Baseline IST.
results showed that in the AQP4 antibody-positive subgroup, 91.1% of patients in the Enspryng-IST treatment group did not relapse, and 56.8% in the placebo-IST treatment group.
, the proportion of patients with severe adverse events in the Enspryng treatment group and the placebo group was similar in both studies.
infection rate (including severe infections) in the Enspryng treatment group was lower than in the placebo group.
Most adverse reactions were mild to moderate, and the most common adverse reactions in the Enspryng treatment group with a rate of more than 15% were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, joint pain, pain in the limbs, fatigue and nausea.
data from the two controlled, randomized Phase III clinical trials above show that Enspryng is an effective treatment option, whether used as a single-drug treatment or in association with baseline therapy.
enspryng is injected every four weeks, which is a convenient treatment option for patients and caregivers.
NMOSD field: Two drugs have been marketed - C5 supplement inhibitor Soliris, B cell expendable upliznaNMOSD new drug, at the end of June 2019, Alexion's first supplement inhibitor Soliris (eculizumab) was approved by the U.S. FDA for anti-AQP4 antibody-positive NMOSD adult patients.
end of August 2019, Soliris was approved by the European Union for use in adult patients with AQP4 antibody-positive NMOSD with a relapse process.
the United States and the European Union, Soliris was the first drug to be approved for NMOSD.
!--/ewebeditor: page -- !--ewebeditor: page title" -- In June this year, Viela Bio's anti-CD19 single-anti-drug Uplizna (in) ebilizumab-cdon, formerly known as MEDI-551), was approved by the FDA as a two-time-a-year maintenance program after the initial dose for the treatment of adult patients with anti-AQP4 antibody-positive NMOSD.
it is worth noting that Uplizna is the first and only B-cell expendable approved for the treatment of adult patients with AQP4 antibody-positive NMOSD.
Uplizna's active pharmaceutical ingredient, inebilizumab, is a humanized CD19-oriented monoclonal antibody with a high affinity with CD19, a protein widely expressed in B cells, including pulp cells that secrete antibodies and some plasma cells.
combined with CD19, these cells are rapidly depleted from the circulatory system.
the end of May 2019, Hansoh Pharma entered into a strategic partnership with Viela Bio to develop in-inebilizumab in China for the treatment of NMOSD and other potential inflammatory/autoimmune and hematological malignancies.
terms of the agreement, Viela Bio is eligible for an upfront partnership fee and milestone payments of more than $220 million, as well as tiered royalties based on net product sales.
Pharmaceuticals will lead the development and commercialization of in-inebilizumab in China.
() Original source: FDA approved Genentech's Enspryng for Neuromyelitis Optica Spectrum !--/ewebeditor:page--