Drug Review Profiles
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Omisirge Review Chronology: From Pre-IND Meeting To Approval
The Pink Sheet charts the 13-year journey from Gamida Cell's initial meeting with the US FDA to Omisirge's eventual approval ahead of an extended user fee date.
Expanding Cells, Expanding Access: Gamida Cell’s Omisirge Debuts New Donor Source For Stem Cell Transplant
Pink Sheet’s Drug Review Profile follows the FDA’s navigation of the first expanded umbilical cord blood graft with the first indication grounded in neutrophil recovery and infection incidence data.
Leqembi Clinical Development: Aduhelm Opened The Door For Accelerated Approval
Timeline of lecanemab’s clinical development shows how, almost three years after telling Eisai and Biogen that their Phase II results did not support regular or accelerated approval, the FDA review division reversed course following its decision to approve aducanumab on a surrogate endpoint.
Leqembi Safety: Label Has Distinct MRI Schedule But Follows Aduhelm On ARIA Management
With the second amyloid-targeting antibody for treatment of Alzheimer’s, US FDA opted for a class-wide approach to management of amyloid-related imaging abnormalities, but with a product-specific MRI monitoring schedule that differs from that of Aduhelm.
Leqembi Phase II Missed Clinical Endpoint But Still Provided Support For Amyloid Surrogate
Pink Sheet's Drug Review Profile digs into the FDA memos on Eisai/Biogen’s lecanemab; Phase II clinical efficacy results were reviewed for whether they supported the likelihood of amyloid plaque reduction to predict clinical benefit, rather than whether they directly provided substantial evidence of effectiveness.
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.
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.
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.
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.
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.
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.
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.
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