US regulators reverse MS decision

Organisation: Position: Deadline Date: Location:

Eleven months after rejecting a powerful multiple sclerosis drug, [b]The Boston Globe[/b] reports that US regulators have reversed themselves and approved sale of the medicine, Lemtrada. The [b]Food and Drug Administration (FDA)[/b] decision came after MS patients across the country called for more treatment options and manufacturer Genzyme submitted a new analysis of clinical data to address FDA concerns about how the company had designed trials to test the drug’s safety and effectiveness.

Patients have been anxiously awaiting the ruling on Lemtrada because studies showed people using it suffered fewer flare-ups of the potentially debilitating autoimmune disease, and about 70% of them were able to stop taking the injectable drug after two treatment courses. Genzyme executives said Lemtrada will be priced at $158,000 for two courses of treatment over two years. Rebif, a competing drug compared with Lemtrada in clinical studies, costs $134,600 for a similar treatment regimen, or 17% less. But Genzyme pointed out that patients on Lemtrada suffered 50% fewer relapses than those taking the other drug.

While the drug already has been approved in more than 40 countries – including [b]EU[/b] nations, [b]Canada, Mexico, Australia[/b], and [b]South Korea[/b] – the US is the world’s largest drug market. In the US, the company said the use of Lemtrada would ‘generally be reserved’ for patients who have previously taken two or more other MS drugs but are still having relapses.

Full report in The Boston Globe

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