US FDA approves ThromboGenics' Jetrea; advisory backing for Aegerion's lomitapide

Belgian drugmaker ThromboGenics NV (Euronext Brussels: THR) yesterday received US Food and Drug Administration approval for Jetrea (ocriplasmin) USA for the treatment of symptomatic vitreomacular adhesion (VMA), a progressive sight threatening condition. Jetrea is the first pharmacological agent to be approved for this indication.

Patrik De Haes, chief executive of ThromboGenics, said: “Today’s FDA approval of Jetrea is a major milestone for the company…We are continuing to prepare for the planned launch of Jetrea in January 2013 through our own US commercial organization. This is the biggest step in transforming ThromboGenics into a profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines.”

The approval was based on the data from ThromboGenics’ Phase III program where Jetrea was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01). Treatment with Jetrea was associated with some, mainly transient, ocular adverse events.