GREY:IPHAF - Post Discussion
Post by
labumba on Nov 01, 2010 10:03pm
few words from Lux
on Luveniq new trial
In early 2010, Lux Biosciences simultaneously submitted a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for LUVENIQ for noninfectious uveitis affecting the intermediate and posterior segments of the eye to the Food and Drug Administration (FDA) and to the European Medicines Agency (EMA), respectively. The review of the MAA by EMA is ongoing. A Complete Response letter regarding the NDA for LUVENIQ was received from FDA in August 2010, in which the FDA requested an additional pivotal trial, which Lux Biosciences is actively planning and is expected to begin before the end of 2010. This new trial will be similar in design to the LX211-01 study, but will include key design improvements.
Lux Biosciences has exclusive worldwide rights to develop and commercialize voclosporin for ophthalmic use under its license with Paladin Labs Inc.
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