European CHMP confirms its recommendation to refuse marketing authorisation for intravitreal bevacizumab (Ipique)
The CHMP has re-examined its initial opinion, and confirmed its recommendation to refuse marketing authorisation for this intravitreal bevacizumab product, which was intended for the treatment of neovascular age-related macular degeneration.
Source:
European Medicines Agency
SPS commentary:
At the time of the initial evaluation, the Agency raised a number of concerns as the literature review was only based on data obtained with other bevacizumab-containing medicines and the company had not submitted any evidence comparing Ipique with another bevacizumab medicine used intravitreally. The concerns did not change after re-examination and the Agency considered its risks outweighed its benefits.