AstraZeneca CTLA-4 Inhibitor Imjudo (Finally) Wins FDA Approval
Pharma To Carve HCC Niche On Survival Data
More than a decade after Pfizer gave up on it, tremelimumab won approval combined with PD-L1 inhibitor Imfinzi for frontline hepatocellular carcinoma, ahead of Bristol’s Yervoy/Opdivo second-line indication.
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AstraZeneca’s CEO criticized controversial draft EU legislation that could cut market protection periods for new therapies launched in the region during a Q1 earnings call that saw promising sales growth in line with full-year guidance.
Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.
Now approved for the treatment as well as the prevention of COVID-19 in the EU and Japan, the UK major’s antibody combo passed the $500m sales barrier in the third quarter and CEO Pascal Soriot is confident that growth will continue.