한국에서 걷어찬(?) '렉키로나' ... EU, 유망 코로나 치료제 선정
한국에서 걷어찬(?) '렉키로나' ... EU, 유망 코로나 치료제 선정
EC, 렉키로나 포함 유망 코로나19 치료제 5종 선정 … 10월까지 최소 3개 승인

셀트리온 “렉키로나, EMA 롤링리뷰 진행 중… 유럽 전역 빠른 공급 위해 최선”
  • 임도이
  • admin@hkn24.com
  • 승인 2021.06.30 12:06
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셀트리온 연구원이 연구를 진행하고 있다.
셀트리온 연구원이 자체 연구를 진행하고 있다.

[헬스코리아뉴스 / 임도이] 국내 보건당국으로부터 변이 바이러스에 효능이 약하다는 지적을 받은 셀트리온의 코로나19 항체 치료제 '렉키로나'가 유럽엽합 집행위원회(EC)에서는 유망한 코로나19 치료제로 선정됐다.

EC는 현지 시간 29일 유럽지역 전체 환자를 치료하기 위한 유망 코로나19 치료제 5개를 선정해 발표했다. EC에서 코로나19 관련 유망 치료제를 선정, 발표한 것은 이번이 처음이다.

EC는 셀트리온 렉키로나를 포함해 유럽의약품청(EMA)에서 롤링리뷰(Rolling Review, 허가신청 전 사전검토 절차)를 진행 중인 항체 치료제 4종과 시판 중인 면역억제제 1종 등 총 5개 치료제를 유망 치료제로 꼽았다.

스텔라 키리아키데스(Stella Kyriakides) 보건 및 식품 안전 담당 커미셔너는 “오늘 우리는 COVID-19를 치료하기 위한 광범위한 치료 포트폴리오로 첫발을 내딛고 있다”며 “백신 접종이 빠른 속도로 진행되는 동안에도 바이러스는 사라지지 않을 것이고 환자들은 COVID-19의 부담을 줄이기 위해 안전하고 효과적인 치료제가 필요할 것”이라고 유망 치료제 선정 배경을 설명했다.

EC는 유망 치료제를 추가적으로 확인하는 한편, 유럽 전역에서 사용 가능한 최소 3개의 치료제를 오는 10월까지 승인하고, 연말까지 총 5개의 치료제를 확보하기 위해 노력한다는 방침이다. 

EC는 특히 “5가지 치료법의 초기 목록은 가장 발전된 COVID-19 치료법의 개발”이라며 “이러한 치료제는 이미 EMA의 평가를 받고 있으며, 임상 데이터가 안전하고 효과적이라고 확인되면 이론적으로 연말까지 승인될 수 있다”고 강조하기도 했다.

셀트리온은 렉키로나 외 다른 3개의 유망 항체 치료제와 함께 현재 EMA에서 롤링리뷰를 진행 중에 있으며, 최근 안전성과 유효성을 확인한 렉키로나 글로벌 임상 3상 결과도 EMA에 제출을 완료한 것으로 알려졌다.

셀트리온은 또 각종 코로나19 변이 바이러스에 대한 긍정적인 동물효능시험 결과를 확보해 세계 각국의 규제기관에 제출하는 등 렉키로나 허가를 위한 작업에 속도를 내고 있다.

셀트리온 관계자는 헬스코리아뉴스에 “렉키로나에 대한 EC의 유망 치료제 선정은 유럽연합 전문가들이 객관적이고 과학적인 판단에 의해 이뤄진 결과”라며 “진행 중인 EMA 롤링리뷰에 집중해 렉키로나가 유럽 전역의 코로나19 치료제로 활용되도록 최선을 다하고, 현재 확산되는 변이 바이러스에 대해서도 대응 가능한 적절한 치료제 개발에 전념하겠다”고 말했다.

한편, 질병관리청 산하 국립보건연구원은 지난 25일, 코로나19 항체치료제 ‘렉키로나’가 국내 유행 변이주(B.1.619, B.1.620)에는 중화능(바이러스 무력화)이 유지됐으나, 인도발 델타형 변이에 대한 중화능은 현지히 감소됨이 확인됐다고 밝힌 바 있다.

이에대해 셀트리온측은 “세포주 수준의 실험과 함께 인도발 델타형, 브라질발 감마형 변이에 대해 실제 인체에서의 효능을 예측할 수 있는 동물효능실험을 국내외 공신력있는 기관과 협력해 실험 중에 있다”며 “7월 초까지 순차적으로 결과 도출 시에 신속히 발표할 계획”이라고 밝혔다. [아래 관련기사 참조]

[EC 보도자료 바로가기] 

Press release29 June 2021Brussels

COVID-19 Therapeutics Strategy: Commission identifies five promising candidate therapeutics

The EU Strategy on COVID-19 Therapeutics delivers today its first outcome, with the announcement of the first portfolio of five therapeutics that could soon be available to treat patients across the EU. Four of these therapeutics are monoclonal antibodies under rolling review by the European Medicines Agency. Another one is an immunosuppressant, which has a marketing authorisation that could be extended to include the treatment of COVID-19 patients.

Commissioner for Health and Food Safety, Stella Kyriakides, said: “Today we are taking the first step towards a broad portfolio of therapeutics to treat COVID-19. Whilst vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19. Our goal is clear, we aim to identify more front-runner candidates under development and authorise at least three new therapeutics by the end of the year. This is the European Health Union in action.”

The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorisation by October 2021, the target set under the Strategy, provided the final data demonstrate their safety, quality and efficacy. The products are:

A new COVID-19 indication for existing medicines:

baricitinib immunosuppresant (a medicine that reduces the activity of the immune system) from Eli Lilly: an application for extension of marketing authorisation for COVID-19 indication is under assessment

Newly developed monoclonal antibodies under rolling review - a regulatory tool to speed up the assessment of a promising medicine during a public health emergency:

combination of bamlanivimab and etesevimab from Eli Lilly: under rolling review

combination of casirivimab and imdevimab from Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd: under rolling review

regdanivimab from Celltrion: under rolling review

sotrovimab from GlaxoSmithKline and Vir Biotechnology, Inc.: under rolling review

Next Steps

The Commission will draw up a portfolio of at least 10 potential COVID-19 therapeutics by October, building on the work of the newly established expert group on COVID-19 variants.  The selection process will be objective and science based, with selection criteria agreed with the Member States. Since different types of products are needed for different patient populations and different stages and severity of the disease, the expert group will identify product categories and select the most promising therapeutics candidates for each category based on science based criteria. 

The portfolio will contribute to the objective of having at least three new therapeutics authorised by October and possibly two more by the end of the year. The European Medicines Agency will start more rolling reviews of promising therapeutics by end-2021, subject to research and development outcomes.

The Commission recently concluded a joint procurement of monoclonal antibodies (casirivimab and imdevimab) and could launch more by the end of the year.

The first industry matchmaking event on therapeutics will be organised on the 12-13 July to ensure that once authorised therapeutics are produced in sufficient quantity as soon as possible.

Background

The EU Strategy on COVID-19 Therapeutics aims to build a broad portfolio of COVID-19 therapeutics with the goal of having three new therapeutics available by October 2021 and possibly two more by the end of the year. It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use.

The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve resilience of Europe's health systems.

The Strategy, which focuses on the treatment of patients with COVID-19, works alongside the successful EU Vaccines Strategy, through which safe and effective vaccines against COVID-19 have been authorised for use in the EU to prevent and reduce transmission of cases, as well as hospitalisation rates and deaths caused by the disease.

Questions and answers29 June 2021Brussels

Questions and Answers: COVID-19 Therapeutics Strategy – list of 5 candidate therapeutics

Why do we need a list of the five most promising COVID-19 therapeutics?

While the COVID-19 vaccination campaign progresses well in Europe, the availability of therapeutics for affected patients is still limited, with so far one product, remdesivir, authorised at EU-level. On 6 May 2021, the European Commission published the EU Strategy on COVID-19 therapeutics, which addresses therapeutics research, development, authorisation, manufacturing and deployment.

The EU COVID-19 Therapeutics Strategy maps out a number of actions to identify candidate therapeutics. The Commission has committed under the strategy to establish a list of five promising candidates by June 2021. A broader portfolio of ten potential candidates will follow by October 2021. An interactive mapping platform for promising therapeutics will be set up under the Health emergency preparedness and response authority (HERA) by mid-2022. The Commission is also preparing a COVID-19 ‘therapeutics innovation booster platform' to take stock and develop a clear overview of the COVID-19 therapeutics projects under earlier stages of development in order to better support development of potential therapeutics.

What are the criteria for selecting the first five therapeutics?

The list is based on objective criteria, namely the rolling review evaluation by the European Medicines Agency (EMA). A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicinal products during a public health emergency. EMA includes products in the rolling review procedure based on promising preliminary results from clinical studies. There are currently five front-runner COVID-19 treatments under evaluation by EMA. These products are in an advanced stage of development and have a high potential to be among the new COVID-19 therapeutics to receive authorisation.

How will you get from the list of five to a broader portfolio (list of ten)?

The initial list of five therapeutics is a snapshot of the most advanced COVID-19 therapeutics in terms of development. These therapeutics are already under evaluation by EMA, and they can theoretically be approved by the end of the year, if clinical data confirm that they are safe and efficacious.

The Commission is also working on a framework for a broader and diverse portfolio of therapeutics with the help of the HERA expert group on variants. Initially it will be a list of at least 10 therapeutics and evolve into a continuous mapping of therapeutics development. The portfolio will indicate products in the research and development pipeline which have the potential to serve as the EU's future therapeutic arsenal to fight the disease, and should remain live and dynamic given the emerging and circulating variants.

As opposed to the list of five, which only takes into account the rolling review process, the broader portfolio will be based on more criteria to be defined by the expert group. The selection process will be objective and science based and the selection criteria will be also agreed with the Member States.

Since different types of products are needed for different patient populations and different stages and severity of the disease, the expert group will identify product categories and select the most promising therapeutics candidates for each category.  Rather than a list only, the diverse portfolio will provide a mapping of the most advanced candidates in the different categories, evolving as candidates progress or fail. The portfolio could be used also as the basis for other activities in the strategy, such as the Innovation Booster, HERA, EU-FAB, match-making events, joint procurement, advance purchase agreements, innovation partnership and rescEU stockpiling.

What will be the benefit of including a product on the list of therapeutics?

For the moment, there are no specific financial instruments attached to the portfolio, however the relevant candidates will benefit from regulatory flexibility as set out in the Therapeutics Strategy, while making sure medicinal products are safe and efficacious. Examples of flexibility are rolling reviews, conditional marketing authorisations, or flexible labelling and packaging requirements. They can also benefit from scientific support by EMA or by the match making activities under the EU therapeutics strategy.

Nevertheless, the portfolio approach will support the strategy's ambition to authorise three new therapeutics by October 2021, and possibly two more by the end of the year. It will also facilitate the identification of suitable candidates for joint procurement.

What if a product has not been included in the list of five?

The Commission is working on a broader and diverse portfolio of therapeutics. The portfolio will cover different types of products needed for different patient populations and different stages and severity of the disease. It will identify the types of products that are in the pipeline and the products that are still needed, as well as the gaps in treatment options.

When will the five therapeutics on the list be authorised?

Given that these products are in an advanced stage of development (under the rolling review process) they have a high potential to be among the three new COVID-19 therapeutics to receive an authorisation (by October 2021), provided the final data demonstrate their safety, quality and efficacy.

Why are a majority of the five therapeutics monoclonal antibodies?

Due to the complexity of the COVID-19 disease, a multitude of agents are under development, e.g. antivirals, immuno-modulators, anti-inflammatory agents. Candidates include small molecules, monoclonal antibodies as well as cell-based therapies. Ongoing clinical trials look at the safety and efficacy of products under development in different stages of disease: e.g. early, mild, moderate, severe COVID-19 disease; and in different patient subpopulations: ambulatory and hospitalised patients; people exposed to infection and long COVID sufferers.

Four therapeutics currently under rolling review by the EMA are antiviral monoclonal antibodies, targeting a protein (spike protein) on the surface of the SARS-CoV-2 virus that causes COVID-19, preventing the virus to enter the body's cells.  Their inclusion in the rolling review procedure has been based on the promising preliminary results from clinical studies.  Different to monoclonal antibodies, baricitinib is an immunosuppressant (a medicine that reduces the activity of the immune system), currently authorised for use in adults with moderate to severe rheumatoid arthritis or atopic dermatitis.

What are you doing on joint procurement?

On 8 October 2020, the Commission signed a joint procurement framework contract with the pharmaceutical company Gilead for the supply of up to 500 000 treatment courses of remdesivir, the only medicine with an EU wide conditional marketing authorisation in for the treatment of COVID-19 patients needing oxygen supply. All participating countries were able to place their orders to procure remdesivir directly. The Commission also purchased and distributed to Member States doses for a total of €70 million. Since late October 2020, the Commission has signed over 70 joint procurement contracts for 19 medicines (analgesics, antibiotics, muscle relaxers, anaesthetics, resuscitation), including dexamethasone, to treat more severe COVID-19 cases in Intensive Care Units.

A joint procurement contract for the combination product consisting of casirivimab and imdevimab was signed in April 2021 and negotiations regarding the joint procurement of other monoclonal antibodies are ongoing. 


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