FDA stiff-arms Aveo on tivo, again; Sunovion Parkinson's drug rejected
→ Aveo Oncology was hit with a fresh setback on Thursday. Its 2013-rejected tivozanib is still not ready for a new marketing application, the company said, citing FDA feedback. The agency recommended that the drug developer not submit the application as preliminary overall survival data — reported last November — did not allay their concerns about the drug’s use in renal cell carcinoma outlined in their rejection letter in 2013. The new application will be made once mature OS results are available. “We are hopeful that the positive PFS (progression-free survival) outcome will translate into an improved hazard ratio when we evaluate a more mature interim OS outcome in the fourth quarter of 2019,” said Aveo chief Michael Bailey said in a statement. The company’s shares $AVEO cratered more than 55% in early trading.
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