Research and Markets: Generic Drug Opportunity Assessment – Fingolimod (Gilenya)

http://www.researchandmarkets.com/research/t2hnb5/generic_drug) has announced the addition of the “Generic Drug Opportunity Assessment – Fingolimod (Gilenya)” report to their offering.

Gilenya (fingolimod) is the first in a new class of multiple sclerosis (MS) therapies called sphingosine 1-phosphate receptor modulators and the first oral therapy approved to treat relapsing-remitting MS (RRMS). In the US, Gilenya is indicated for relapsing forms of MS. In the EU, Gilenya is indicated for adult patients with highly active RRMS defined as either high disease activity despite treatment with beta interferon, or rapidly evolving severe RRMS. A Phase II/III study of Gilenya in patients with chronic inflammatory demyelinating polyradiculoneuropathy was initiated in 2012. In 2012 Gilenya continued to show rapid growth as the first once-daily oral therapy approved for relapsing remitting and/or relapsing forms of multiple sclerosis (MS and RRMS) in adult patients, and achieved $1.2 billion in annual sales.

The Market

The Multiple Sclerosis market has been dominated by injectables – interferons and more recently Teva’s Copaxone. It is believed that interferon medications such as Rebif, Betaferon, and Avonex are effective against MS because they help regulate the immune system to decrease attacks on myelin. Rebif has been shown to be effective in treating patients with relapsing-remitting MS. The interferons have been shown to reduce relapses in relapsing-remitting MS, though not for primary progressive multiple sclerosis, for which there are currently no disease-modifying treatments proven to be effective.

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