Fingolimod is an immune-modulating chemical drug used to treat MS. It diminishes auto-immune reactions and has been shown to reduce the rate of relapses in relapse-remitting MS by approximately half over a two-year period. The drug has been marketed by Novartis as Gilenya since 2010 and there have to date been no generic versions available in the US.

FDA has approved three generic formulations of the drug, by Biocon Ltd, HEC Pharm Co Ltd, and Sun Pharmaceutical Industries Ltd. The treatment is taken orally and has been approved for the treatment of patients aged 10 years and above, making it the first agent approved for paediatric MS.

Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock said in a statement: ‘Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high quality generic medicines’.

The treatment was approved based on data from two trials showing benefit compared to placebo and interferon beta, a biological treatment used to treat MS. The trials showed higher efficacy in reducing relapse rates and preventing new or enlarging brain lesions.

The Administration has also approved a generic of Allergan’s treatment for benign prostatic hyperplasia, Rapaflo (silodosin). The treatment is an alpha-1 blocker with high selectivity for the prostate. It has been approved in the US since 2008.

Alembic Pharmaceuticals received FDA approval for their generic silodosin capsules in two doses (4 mg and 8 mg). The Indian multinational now has a total of 96 final FDA approvals, together with 12 tentative approvals.

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