Outlook Pulls Bevacizumab BLA As Filing Falls Short
Plans To Submit Revised US Application With FDA In Q3
Pinning its hopes on its proposed bevacizumab product for ophthalmic indications, Outlook Therapeutics has been told to give more information to the US FDA ahead of an approval. However, one analyst remained upbeat for the company’s prospects.
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As the fourth quarter of the year nears, plenty is on the horizon for industry, with senior management shifts and a slate of high-value launches in the US and Europe.
The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.
The European Medicines Agency has been asked to re-examine its rejection of the EU marketing application for Ipique, which, if approved, could become the first drug containing bevacizumab to be authorized for use in neovascular (wet) macular degeneration.