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Drug Review Profiles

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Amylyx’s Relyvrio: US FDA Review Shows Regulatory Flexibility Can Come In Many Forms

Pink Sheet Drug Review Profile looks at how the agency determined that Amylyx’s ‘conceptual basis’ for use of the drug’s two active ingredients to treat ALS was enough to satisfy the combination drug rule; the sponsor also was allowed to submit certain animal studies and drug-drug interaction data during the course of the NDA review.

Drug Review Profile Approvals

Early PHOENIX Data Would Not Have Aided Approval Decision On Amylyx’s Relyvrio – US FDA

Agency considered Amylyx’s plan to submit unblinded efficacy data from the ongoing Phase III trial during the ALS drug's NDA review but ultimately decided against it, citing concerns about study integrity and the small amount of data likely to be available.

Drug Review Profile Drug Review

Real-World Evidence: Amylyx’s Use Of External Controls To Frame Relyvrio’s Survival Benefit Rife With Problems

The post hoc comparison of an exploratory, long-term survival benefit in the CENTAUR trial to historical controls in two ALS patient databases lacked prespecification and a common treatment protocol, and potential differences in prognostic factors may have confounded the results.

Drug Review Profile Drug Review

Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements

European Medicines Agency insisted on a stricter statistical analysis than the US FDA for demonstrating equivalence on the primary endpoint for both Coherus/BioEq’s Cimerli and Samsung Bioepis’ Byooviz; there also were differences in the regulators' preferred primary analysis population and primary endpoint interval.

Drug Review Profile Biosimilars

Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis

Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.

Drug Review Profile Biosimilars

US FDA's Spikevax Review By The Numbers

A timeline of the development and approval of Moderna's mRNA vaccine, and a listing of FDA reviewers on the biologics license application.

Drug Review Profile Coronavirus COVID-19

COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US

Five of the six modeling scenarios in the FDA’s quantitative benefit-risk assessment on myocarditis with Moderna’s vaccine assumed Omicron as the dominant circulating strain, with assumed average vaccine effectiveness of only 30% against COVID-19 cases and 72% against hospitalizations.

Drug Review Profile Coronavirus COVID-19

Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape

Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.

Drug Review Profile Approvals

Actemra Review Chronology For SSc-ILD

Detailed timeline of the development and review of Genentech’s Actemra (tocilizumab) in systemic sclerosis-associated interstitial lung disease

Drug Review Profile Approvals

Ponvory’s Regulatory Timeline At The US FDA And EMA

Janssen’s ponesimod for relapsing multiple sclerosis had a slightly faster review in the US.

Europe Drug Review Profile

Fatigue Benefit With Janssen’s MS Drug Ponvory Not Clinically Relevant – US/EU Regulators

In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.

Drug Review Profile Drug Review

EU, US Reviewers Differed On Ponvory’s Secondary Endpoints, But Hierarchy Didn’t Matter In The End

Janssen went against EMA’s advice on the choice of secondary endpoints for its multiple sclerosis drug Ponvory (ponesimod), but still enjoyed a relatively brisk review. The hierarchical order of endpoints did not seem to ruffle any feathers among US FDA reviewers.

Drug Review Profile Drug Review
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