Positive opinions for Novartis' Jetrea and Ilaris from EMA advisory panel

Among a number of positive recommendations last Friday from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) was for the use of Swiss drug major Novartis’ (NOVN: VX) Jetrea (ocriplasmin), for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is an age-related progressive condition that may lead to visual distortion, decreased visual acuity and central blindness, if left untreated. It is estimated that 250,000 to 300,000 patients in Europe suffer from this sight-threatening condition.

Jetrea, a recombinant form of human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pull between vitreous and macula. By dissolving these proteins, Jetrea releases the traction, and helps to complete the detachment of the vitreous from the macula.

Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the USA in March 2012 from Belgium-based ThromboGenics (Euronext Brussels: THR), in a deal worth as much as 375 million euros ($578 million). ThromboGenics retains the rights to commercialize the drug in the USA. In the USA, Jetrea has received US Food and Drug Administration approval for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Last week, ThromboGenics introduced Jetrea in the USA (The Pharma Letter January 15). The first patients have already received this novel treatment in multiple locations across the country.