Novagali withdraws drug marketing application

December 1, 2008

Novagali Pharma SA has withdrawn the EMEA centralized marketing authorization application for Vekacia (cyclosporin) 0.05% eye drops, which had been intended for the treatment of vernal keratoconjunctivitis (VKC).

Novagali Pharma SA has withdrawn the EMEA centralized marketing authorization application for Vekacia (cyclosporin) 0.05% eye drops, which had been intended for the treatment of vernal keratoconjunctivitis (VKC).

The Committee for Medicinal Products for Human Use (CHMP) had concluded that Vekacia's benefit:risk profile was not positive, and had been investigating the drug.

Novagali had originally submitted the Vekacia marketing authorization application on 27 July 2007.