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Lux withdraws Luveniq application

Lux Biosciences has ceased its application for Luveniq to be approved in the EU to treat inflammation of the eye

Lux Biosciences has ceased its application for Luveniq to be approved in the EU to treat inflammation of the eye.

The US-based biopharma had intended the investigational treatment to be used in patients with chronic non-infectious uveitis involving the posterior or intermediate segments of the eyes.

Lux said it was unable to demonstrate to the satisfaction of the Committee for Medicinal Products for Human Use (CHMP) that the benefits of Luveniq outweigh its risks.

The application for the marketing authorisation for Luveniq was initially submitted to the European Medicines Agency (EMA) in Febraury, 2010, and the medicine received a negative opinion by the CHMP on June 23, 2011.

Lux submitted a re-examination request for Luveniq in July 2011.

The medicine was designated an orphan drug by the EMA in September, 2007 due to unmet need in its treatment area.

18th October 2011

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