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Record W6920953531 · doi:10.6084/m9.figshare.12762386

Satralizumab: First Approval

2020· other· en· W6920953531 on OpenAlexaboutno aff

Bibliographic record

VenueFigshare · 2020
Typeother
Languageen
FieldMaterials Science
TopicMultiferroics and related materials
Canadian institutionsnot available
Fundersnot available
KeywordsClinical trialDrug approvalNeuromyelitis opticaDrug developmentInformed consentAuthorizationMarketing authorization

Abstract

fetched live from OpenAlex

Declarations Funding The preparation of this review was not supported by any external funding. Conflict of interest Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest. Ethics approval, Consent to participate and consent for publication, Availability of data and material, Code availability Not applicable. Additional information about this Adis Drug Review can be found here AbstractSatralizumab (Enspryng®), a humanized anti-interleukin-6 (IL-6) receptor monoclonal recycling antibody, has been developed by Chugai Pharmaceutical and Roche for the treatment of neuromyelitis optica spectrum disorder (NMOSD). In June 2020, based on positive results from two pivotal phase 3 trials, SAkuraStar and SAkuraSky, subcutaneous satralizumab received its first global approval in Canada for the treatment of NMOSD in adults and children aged ≥ 12 years who are aquaporin 4 water channel autoantibody (AQP4-IgG) seropositive. Satralizumab was subsequently approved in Japan, Switzerland and the USA. Satralizumab is under regulatory review in the EU, and is undergoing clinical development in several countries worldwide. This article summarizes the milestones in the development of satralizumab leading to this first approval for the treatment of NMOSD. SAkuraStar and SAkuraSky clinical trials additional informationAdditional information about NMO and NMOSD and the SAkuraStar and SAkuraSky trials can be found in two peer-reviewed video abstracts, which are sponsored by Roche and were uploaded to Figshare after the satralizumab AdisInsight Report was published. © Springer Nature Switzerland AG 2020

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.013
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Other · Consensus signal: Other
Teacher disagreement score0.201
Threshold uncertainty score0.672

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0030.013
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0010.001
Science and technology studies0.0010.001
Scholarly communication0.0030.001
Open science0.0010.001
Research integrity0.0040.003
Insufficient payload (model declined to judge)0.2010.124

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.038
GPT teacher head0.248
Teacher spread0.209 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreOther

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2020
Admission routes1
Has abstractyes

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