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- 06/27/2017

AVEO Pharma is on track to get EU approval of its cancer drug

Pharma Horizon

After few rocking years, last friday Aveo has received good news. The scientific committee of the European Medicines Agency recommended tivozanib for approval and as it happens the decision will be considered by the European Commission. The approval is expected in about 67 days.

The drug will be then sold by a licensee in Europe, EUSA Pharma Inc,  under the brand name Fotivda, with Aveo due to collect milestone payments and royalties.

 Tivozanib is intended for advanced renal cell carcinoma, which is the most common type of kidney cancer and is expected to be one of the fastest growing cancers in the next decade.

Back in 2013  AVEO failed to receive FDA approval for tivozanib, however the company is expected in the first quarter of 2018 to report data from a Phase 3 study that  if successful, it would set the stage for the company to seek approval from the FDA.

If the drug gets approval, it would trigger a $4 million payment to Aveo from the European licensee, EUSA Pharma.

European approval of tivozanib would “add significant resources to our balance sheet as we work toward the anticipated readout,”  Aveo CEO Michael Bailey said in a statement.

Furthermore  the company is also examining tivozanib as a potential combination treatment with Bristol Myers-Squibb’s cancer drug Opdivo

 

Source: Boston Business Journal