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.
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Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments
Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.
Genentech's interleukin-6 inhibitor got bonus approval based on data from development programs for Novartis' and Kite's chimeric antigen receptor T-cell therapies; CAR-T developers allowed FDA to access the Actemra-related data in their applications and conduct its own pooled analysis.
GlaxoSmithKline's Coreg labeling states that data show a mortality risk reduction of 23% in patients taking the drug after suffering a myocardial infarction