FDA requires further study for oral voclosporin

August 27, 2010

The FDA has issued a complete response letter regarding a new drug application (NDA) for oral voclosporin (Luveniq, Lux Biosciences) for the treatment of non-infectious uveitis, according to the company.

Jersey City, NJ-The FDA has issued a complete response letter regarding a new drug application (NDA) for oral voclosporin (Luveniq, Lux Biosciences) for the treatment of non-infectious uveitis, according to the company.

The FDA issues such a letter when it has reviewed a file but has questions that preclude the approval of the NDA in its current form. Lux Biosciences and its partner, Isotechnika Pharma, are evaluating the letter but indicate that the agency said that it regards the data from one of the two pivotal studies submitted in the NDA as positive. Officials at Lux Biosciences said the company plans to begin an additional pivotal trial of oral voclosporin before the end of the year.

“We continue to work with FDA to address [its] outstanding questions regarding the safety and efficacy of [oral voclosporin], and the Lux Biosciences’ Board of Directors is supportive of our starting the additional trial,” said Dean Mitchell, Lux Biosciences’ president and chief executive officer. “At the same time, the European Medicines Agency review of the marketing authorization application [MAA] for [oral voclosporin] remains on course for completion in the first quarter of 2011.”

The company announced submission of the NDA and MAA for oral voclosporin Feb. 3.