Spring Intro 2023

16/02/2023

EFFICACY: NEW INDICATION & ‘LABEL’ ENHANCEMENT VARIATIONS

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Why Important?

● Treat more patients: – Completely new indication e.g. Zeposia – Different sub-populations e.g. Prezista adults  paediatrics – Different target e.g. Xalkori NSCLC, ALK-positive  ROS1-positive ● Treat different stage of disease: – Moving to earlier line of treatment e.g. Zytiga mCRPC w/disease progression  mCRPC asymptomatic / mildly symptomatic – Zykadia, NSCLC, broadened indication to include 1 st line therapy ● Monotherapy / combination therapy: – Victoza: Type II diabetes, combination therapy  monotherapy – Enbrel: RA monotherapy  combination with MTX, updated SoC ● Maximise treatment effects: – Optimise B/R considerations e.g. Tysabri DMT switch (JC virus index) – Support effectiveness (HTA & reimbursement) ● Extend Information Protection (IP) e.g. + 1 year EU RDP for “significant benefit” : e.g. addition of patient population – paediatric

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