Policy & Regulation
FDA to grant Priority Review status to ThromboGenics' ocriplasmin
2 February 2012 - ThromboGenics NV (EBR:THR), a Belgian biopharmaceutical company active in the discovery and development of treatments of eye disease, vascular disease and cancer, said on Thursday that the US Food and Drug Administration (FDA) plans to grant its ocriplasmin BLA (Biological License Application) for Priority Review.

The Priority Review designation is granted to drugs that may offer major advances in treatment, or provide a treatment for diseases with no adequate therapy.

The FDA has a goal of completing a Priority Review in just six months.

As a result, ThromboGenics has pulled out its current filing and will re-submit a BLA for ocriplasmin for symptomatic VMA including macular hole by April 2012. The re-submission will allow ThromboGenics to meet the pre-approval inspection timelines.
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