More bad news for Merck KGaA's Cladribine hit the press today. The oral drug for multiple sclerosis was rejected by European Medicines Agency (Europe's equivalent of the FDA), as they said that the risks of the drug outweighed potential benefit. In trial, 2% of participants on the drug developed shingles and 4 people developed cancer, while neither of these things were seen in the placebo group.
The FDA is handing down their ruling on cladribine at the end of February. The drug is already approved for use in Russia and Australia.
Merck officials are keeping their composure (in public, at least). They are continuing with trials that will end in early 2012, at which time they plan to resubmit their application to the European agency with this "new clinical data." I guess that is assuming that there is positive news in the data.
At one point, the two oral MS candidates were in a tight competition to see which one would hit market first: cladribine or Gilenya (fingolimod). We know how that turned out - in the US, at least, as Gilenya is already on the market here. Novartis is still waiting for European approval for Gilenya, possibly as soon as the end of this month.
Read a little about the history of the race to be the first oral MS med here:
- Jan 8, 2009 Oral Multiple Sclerosis Drug More Effective, According to Trial Results
- Jan 26, 2009 What's Up With Oral Drugs for Multiple Sclerosis?
- Jan 27, 2009 Merck Says Oral Drug for Multiple Sclerosis Coming Soon
- Feb 16, 2009 How Much Is The Multiple Sclerosis Pill Worth? 1.3 Billion a Year.
- June 15, 2010 Oral MS Drug Moves Forward at FDA
- June 15, 2010 Will You Switch to an Oral MS Drug?
- July 27, 2010 How Neuros Will Use the Oral Drugs for MS
- July 27, 2010 Neuros More Aware of Cladribine than Fingolimod (FTY720)
- September 28, 2010 Gilenya (aka Fingolimod): When and How Much?
- October 1, 2010 Gilenya Costs $48000 per Year
