EMA Rejects Bevacizumab Drug For Use In Wet AMD
European Commission Approves COVID-19 Products Ronapreve & Regkirona
Nearly a year and a half after it was filed for approval, the EU regulator has rejected a mystery injectable product containing the monoclonal antibody bevacizumab for ophthalmic use.
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The EMA’s CHMP has issued positive opinions for two insulin biosimilars: Sanofi’s insulin aspart rival to NovoMix and Baxter’s insulin human (rDNA) version of Actrapid. At the same time, the CHMP has confirmed its recommendation to refuse marketing authorization for the Ipique ophthalmic version of bevacizumab.
Positive CHMP opinions recommending European marketing authorizations have been granted for Accord’s teriparatide and Fresenius Kabi’s pegfilgrastim biosimilars, while the sponsor for an ophthalmic version of bevacizumab has asked the EMA to take a second look at the rejection of its application. Three Accord generics were also endorsed by the CHMP at its January meeting.
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.