Tigilanol tiglate injection (STELFONTA®): Three Continents and 20,000 Cases and Wisdom from Wins, Learning from Pitfalls

Presentation Description / Summary: Tigilanol tiglate has been approved globally on three continents by five regulatory agencies (European Medicines Agency, Veterinary Medicines Directorate, Swissmedic, US Food and Drug Administration, Australian Pesticides and Veterinary Medicines Authority). More than 20,000 cases have been treated globally over the course of the last four years. Although new drug products undergo extensive safety and efficacy studies to achieve regulatory approval, much of what we learn about a drug comes from the first few years of clinical use in the ‘real’ world. This lecture will share learnings from pharmacovigilance reporting, subsequent clinical trials and shared clinician experiences over that time period.

Learner Outcomes: • Discover the ongoing safety and efficacy evaluation of the drug along with valuable clinical insights to ensure successful case outcome. • Learn the importance and requirements of pharmacovigilance monitoring in post-market approval stages of new drugs on the market. • Understand the importance of label indications and case selection for patient safety and efficacy.