Gilenya market share drops after FDA review

An FDA safety review is taking its toll on Gilenya sales. The Novartis ($NVS) multiple sclerosis pill, the first oral therapy for the debilitating disease, lost market share in January after reports that some patients died while using the drug, one of them soon after taking his first dose. Some doctors say they're being more cautious about prescribing the drug, but Novartis says Gilenya's "potential is seen as unchanged."

As Bloomberg reports, the decline was small--to 6.1% of the market for immunomodulatory drugs, from 6.2%--but it came after 15 months of growth at a median rate of 15% per month. Meanwhile, analysts have cut their sales forecasts for the pill an average of 10%. As a group, they now expect about $2.1 billion in sales by 2016.

Novartis counters the market-share figures from the market resesarchers at Wolters Kluwer by saying that it has seen an uptick in U.S. scripts over the past few weeks. The company said a record number of new prescriptions have recently rolled in. "Some uncertainty is to be expected ... as some physicians wait for final review and potential label changes" from the FDA, the company told Bloomberg. "Overall, we see Gilenya continuing to grow in volume."

Martin Voegtli of Kepler Capital Markets told the news service that he's cut his Gilenya sales forecasts to $1.96 billion by 2016. But he expects the safety concerns to wear off. "We still expect Gilenya to remain on the market and return to growth once the review has been completed," he said.

- read the Bloomberg story