FDA to review oral MS drug Lemtrada

[MSUK]

Genzyme Inc. said today the U.S. Food and Drug Administration has accepted for review the Cambridge-based company’s application seeking approval of Lemtrada to treat relapsing multiple sclerosis.

The company said it expects FDA action on the application in the second half of 2013. Genzyme added it has already submitted its marketing authorization application for Lemtrada to the European Medicines Agency and the review process is under way.

Treatment with Lemtrada, commonly known as alemtuzumab, results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in multiple sclerosis.

Genzyme also reported highlights from the U.S. launch of its once-daily oral medication Aubagio, which is also used to treat patients with relapsing forms of multiple sclerosis. The company said since its October launch, the drug has been prescribed by more than 80 percent of MS specialists.

Aubagio is approved for use in both the United States and Australia.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1307

[LR1234]

Its not oral by the way (I think its campath)

[euphoniaa]

Its not oral by the way (I think its campath)

Yes, it's Campath, and here are a couple quotes from articles.
From Bloomberg in October:
http://www.bloomberg.com/news/2012-10-1 ... eline.html

Aubagio is an oral therapy. Lemtrada is administered through infusions for five consecutive days when they begin the treatment and for another three days 12 months later. Patients probably will use Aubagio in the earlier phases of the disease, while Lemtrada is more likely to be used at a more advanced stage, neurologists say.

And from Reuters in October:

Sanofi draws fire over cost of MS drug Lemtrada
Wed, Oct 31 2012

Although Campath remains available free of charge to leukaemia patients, Sanofi's rare disease unit Genzyme pulled it off the market in September to prevent its unauthorised use as an MS drug. Analysts said the move would allow the company to adjust the price to match that of rival MS drugs on the market.

A full course of Campath, which in 2011 had sales of $76 million, cost around $60,000 when given three times a week for up to 12 weeks, according to Genzyme. Lemtrada, instead, is given at less than half the dose of Campath for 5 consecutive days and then again for 3 days a year later. Since the drug has yet to be approved, it remains unclear how much Sanofi will charge for it.

The drug, which works by resetting a person's immune system, has shown in late-stage trials to be an effective treatment for MS patients who have failed to respond to other therapies. It has also shown to benefit people not previously treated for the disease, suggesting it could be used as a first-line MS therapy.

But patients need regular monitoring for serious side effects that can include infections and autoimmune diseases. "It's important that the appropriate safety monitoring is in place for patients who are prescribed Lemtrada," Genzyme's head of MS, Bill Sibold, told Reuters, responding to questions about the Lancet editorial. "Until an approved risk-management program is established, we believe the use of Lemtrada should only occur in clinical trials."

P.S. There is a Campath forum here at TiMS.