June 20, 2021

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Roche IL-6R monoclonal antibody Enspryng is about to be approved in EU

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Roche IL-6R monoclonal antibody Enspryng is about to be approved in EU

 

Roche IL-6R monoclonal antibody Enspryng is about to be approved in the EU, and China enters the priority review!

Roche recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting that Enspryng (satralizumab) be approved as a monotherapy or combined immunosuppressive therapy (IST).

For the treatment of neuromyelitis optica spectrum disorder (NMOSD) adolescents (≥12 years old) and adult patients with positive anti-aquaporin-4 antibody (AQP4-IgG).

NMOSD is a rare, lifelong, debilitating autoimmune disease of the central nervous system, which mainly damages the optic nerve and spinal cord, and can lead to blindness, muscle weakness and paralysis.

Approximately 70-80% of NMOSD patients have AQP4-IgG, and these patients often experience a more severe course.


Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months. If approved, Enspryng will be the first and only drug in the EU that can be used for both adults and adolescents (≥12 years old) to treat AQP4-IgG seropositive NMOSD. Enspryng is the only subcutaneous treatment option for NMOSD and can be administered at home every 4 weeks.


So far, Enspryng has been approved in 20 countries, including the United States, Canada, Japan and Switzerland. Regulatory reviews in multiple countries are underway. In China, Enspryng was included in the priority review and approval procedure in July 2020. It has been granted Orphan Drug Designation (ODD) in Japan, the United States, the European Union, and Enspryng, and has also been awarded Breakthrough Drug Designation (BTD) in the United States.


It is worth mentioning that Enspryng is the first and only subcutaneous treatment program approved by the US FDA for the treatment of AQP4-IgG seropositive NMOSD. It can be injected subcutaneously every 4 weeks by the patient or a caregiver.

At the same time, Enspryng is the first and only treatment plan that targets the inhibition of interleukin-6 receptor (IL-6R) activity to treat NMOSD.

In 2 key phase III studies, Enspryng, as a monotherapy and as an add-on therapy to baseline immunosuppressive therapy (IST), showed strong efficacy in a broad population of NMOSD patients and significantly reduced the risk of recurrence.

Roche IL-6R monoclonal antibody Enspryng is about to be approved in EU


NMOSD is usually associated with pathogenic antibodies (anti-AQP4 antibodies), which target and damage specific cells called astrocytes, causing inflammatory lesions in the optic nerve, spinal cord, and brain. Anti-AQP4 antibodies can be detected in the serum of approximately 70-80% of NMOSD patients, and these patients tend to experience a more severe course of the disease. Although most cases of NMOSD can be confirmed by diagnostic testing, up to 30% of patients are still often misdiagnosed as multiple sclerosis (MM).


Patients with NMOSD will experience unpredictable severe relapses, directly leading to cumulative and irreversible nerve damage and disability. Early treatment to prevent recurrence can have a positive impact on the prevention of disability, which is the primary goal of NMOSD disease management.


Enspryng is a humanized monoclonal antibody that targets the interleukin 6 receptor (IL-6R), which is thought to play a key role in inflammation in NMOSD patients. The drug was developed by Chugai Pharma, a subsidiary of Roche, using new antibody recovery technology. Compared with traditional technology, this technology can extend the duration of antibody circulation, minimize IL-6 signaling, and minimize the safety risks in chronic diseases.


Levi Garraway, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “In the EU, there are limited treatment options for NMOSD patients. Today’s positive review of CHMP is an important step in providing Enspring to EU NMOSD patients. The drug has been proven It can significantly reduce the risk of recurrence while also providing good safety. In addition, if approved, Enspryng will be the first and only treatment that can be self-injected subcutaneously at home after proper training.”


Roche IL-6R monoclonal antibody Enspryng is about to be approved in EU
NMOSD (Image source: empr.com)


CHMP’s positive review opinions are based on the positive results of one of the largest key clinical trials for NMOSD. Data from two randomized controlled phase III studies (SakuraStar, SAkuraSky) confirmed that in patients with AQP4 antibody-positive NMOSD, Enspryng was used as a monotherapy and combined with baseline immunosuppressive agents (IST, commonly used to manage relapse-related NMOSD symptoms) The treatment has a strong and long-lasting effect and good safety: Compared with placebo, Enspryng significantly reduces the risk of recurrence, and the effect lasts up to 96 weeks.


-SAkuraStar study: carried out in adult patients with NMOSD to evaluate the efficacy and safety of Enspryng monotherapy and placebo. The results showed that in the AQP4 antibody-positive subgroup, at the 48th week of treatment, 83% of the patients in the Enspryng treatment group had no recurrence and 55% in the placebo group; at the 96th week of treatment, 77% of the patients in the Enspryng treatment group There was no recurrence, 41% in the placebo group.


-SAkuraSky study: carried out in NMOSD adult and adolescent patients, to evaluate the efficacy and safety of Enspryng combined with baseline IST and placebo combined with baseline IST. The results showed that in the AQP4 antibody-positive subgroup, 92% of patients in the Enspryng+IST treatment group had no recurrence at the 48th week and 96th week, while the placebo+IST treatment group had 60% at the 48th week and the 96th week. % And 53% of patients had no recurrence.


In the phase 3 study, Enspryng has good safety and tolerability. The most common adverse reactions observed in safety populations are headache, joint pain, decreased white blood cell count, hyperlipidemia, and injection-related reactions.

The data from the above two controlled, randomized phase III clinical trials show that Enspryng is an effective treatment option whether it is used as a single-agent therapy or in combination with baseline therapy. Enspryng is injected subcutaneously every four weeks, which is a convenient treatment option for patients and caregivers.

NMOSD field: 3 drugs are already on the market-IL-6R inhibitor Enspryng, C5 complement inhibitor Soliris, B cell depleting agent Uplizna

Roche IL-6R monoclonal antibody Enspryng is about to be approved in EU

In terms of new NMOSD drugs, at the end of June 2019, Alexion’s first complement inhibitor Soliris (eculizumab) was approved by the US FDA for use in adult patients with anti-AQP4 antibody-positive NMOSD.

At the end of August 2019, Soliris was again approved by the European Union for use in adult NMOSD patients with positive AQP4 antibodies and a relapsed course. In the United States and the European Union, Soliris is the first drug approved to treat NMOSD. It is worth mentioning that in December 2020, AstraZeneca announced the acquisition of Alexion for US$39 billion. The transaction has recently passed the US antitrust review.

In June 2020, Viela Bio’s anti-CD19 monoclonal antibody drug Uplizna (inebilizumab-cdon, formerly known as MEDI-551) was approved by the US FDA as a twice-a-year maintenance regimen after the initial dose for the treatment of anti-AQP4 antibody positive Adult patients with NMOSD. It is worth mentioning that Uplizna is the first and only B cell depleting agent approved for the treatment of AQP4 antibody-positive adult patients with NMOSD.

Uplizna’s active pharmaceutical ingredient, inebizumab, is a humanized CD19-directed monoclonal antibody that has a high affinity for CD19. CD19 is a protein widely expressed in B cells, including plasmablasts that secrete antibodies and some plasma cells . After inebilizumab binds to CD19, these cells are quickly exhausted from the circulatory system.

At the end of May 2019, Hansoh Pharma and Viela Bio reached a strategic cooperation to develop inebilizumab in China to treat NMOSD and other potential inflammatory/autoimmune and hematological malignancies indications. According to the terms of the agreement, Viela Bio is eligible to receive an upfront cooperation fee and milestone payments of more than $220 million, as well as tiered royalties based on net product sales. Hausen Pharmaceuticals will be responsible for leading the development and commercialization of inebilizumab in China.

 

(source:internet, reference only)


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