Drug Review Profiles
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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.

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.

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

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.

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.

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.

US FDA’s Comirnaty Review By The Numbers
A timeline of the review and development of the first COVID-19 vaccine to win BLA approval.

Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review
Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.

Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis
Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.

Tivozanib’s Efficacy Behind Checkpoint Inhibitors In Renal Cell Carcinoma Reassured US FDA
Approximately 25% of patients in the TIVO-3 trial had prior treatment with checkpoint inhibitors, but progression-free survival in this subgroup was similar to the overall population, giving the FDA confidence about tivozanib's role in contemporary treatment regimens, Drug Review Profile finds.

AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis
After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.
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