19. October 2011 10:19
Lux Biosciences has formally withdrawn its marketing authorisation for Luveniq (voclosporin).
The company stated in its official letter that they were unable to demonstrate to the CHMP that the benefits of the medication outweigh its risks.
But it added that the withdrawal does not have any consequences on any current clinical trials or compassionate use programs.
Luveniq was intended to be used as a treatment option in those with chronic non-infectious uveitis involving the posterior or intermediate segments of the eyes as characterised by a high degree of inflammation.
The medication was designated as an orphan medicinal product in September 2007. The centralised marketing authorisation was first submitted to the EMA in February last year. It received a negative opinion by the CHMP in June this year which saw Lux submit a re-examination request in July.