Novartis (NVS) recently presented new data on Gilenya (fingolimod), which demonstrated that the drug can considerably reduce the rate of brain volume loss.
Gilenya is the first approved once-daily oral therapy for the treatment of relapsing forms of multiple sclerosis (MS). The data also showed that Gilenya reduced annualized relapse rates across patients in different age groups.
Results from three large pivotal phase III studies (TRANSFORMS, FREEDOMS and FREEDOMS II) revealed that Gilenya can significantly lessen the rate of brain volume loss versus a comparator.
Additionally, new extension data from FREEDOMS II reinforces the safety profile of Gilenya in patients who were treated up to four years.
Earlier, in Oct 2012, Novartis presented results from the FREEDOMS (n=1272) and FREEDOMS II (n=1083) studies. These studies revealed that early treatment with Gilenya has a significant positive effect on relapses and magnetic resonance imaging MRI outcomes, including loss of brain volume, in MS patients.
The difference between the drug and placebo was significant by day 82 in FREEDOMS study, whereas the same was observed by day 64 in the FREEDOMS II study.
We note that Gilenya is approved in the US for relapsing forms of MS. In the EU, Gilenya is approved for adult patients with highly active relapsing-remitting MS (RRMS), which is also known as rapidly evolving severe RRMS.
Novartis licensed Gilenya from Mitsubishi Tanabe Pharma Corporation. Gilenya is currently approved in over 65 countries around the world.
Gilenya recorded $349 million of sales in the fourth quarter of 2012, up 74% from the year-ago quarter. For 2012, sales touched $1.2 billion, up 147% from 2011.
Hence, we are encouraged by the new data presented on Gilenya, which should bolster growth for Novartis.
Right now, Novartis carries a Zacks Rank #3 (Hold). Pharma stocks, which currently look more attractive include Novo Nordisk (NVO), Furiex Pharmaceuticals Inc. (FURX), and Abbvie (ABBV) all with a Zacks Rank #2 (Buy).
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