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Novartis' Jetrea Gets EU Approval

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Novartis (NVS - Free Report) recently announced that the European Commission has approved Jetrea intravitreal injection (ocriplasmin) for the treatment of vitreomacular traction (VMT) and macular hole.

Affecting 250,000 to 300,000 people in Europe, VMT causes sight-threatening symptoms, which might result in irreversible vision loss. So far, people suffering from VMT had only surgery as a treatment option for this eye disease.

The approval does not come as a surprise since in Jan 2013 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of Jetrea for the indication.

The approval was based on results from pivotal studies, which demonstrated that patients treated with Jetrea successfully achieved resolution of VMT and closure of macular holes compared to placebo on the 28th day of treatment.

We note that Novartis caters to the eye care market through its division Alcon. Novartis acquired rights to commercialize Jetrea outside the US from Belgian biopharmaceutical company ThromboGenics. However, ThromboGenics retains the right to market the drug in the US.

We remind investors that Jetrea was approved by the US Food and Drug Administration (FDA) in Oct 2012 subsequent to which ThromboGenics launched Jetrea in the US in Jan 2013.

Earlier this month, the EC also approved Novartis’ drug llaris (canakinumab, ACZ885) for an additional indication – treatment of adults suffering from gouty arthritis (gout).

Ilaris is already approved for treating children and adults suffering from cryopyrin associated periodic syndrome (CAPS) in the EU, US, Switzerland and Japan.

We are encouraged by the recent bout of regulatory approvals at Novartis. Right now, Novartis carries a Zacks Rank #3 (Hold). Pharma stocks, which currently look more attractive include Novo Nordisk (NVO - Free Report) , Shire plc (SHPG - Free Report) and Furiex Pharmaceuticals Inc. , all with a Zacks Rank #2 (Buy).

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