UPDATE: Research into Blood Flow in the Brain and Venous Insufficiency, or CCSVI, in MS – Letters of Intent Received from Request for Research Applications Released Worldwide
Updated January 8, 2010
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Biogen Idec says that four more cases of the rare and serious neurological infection known as PML have been detected in patients taking its drug for multiple sclerosis, Tysabri.
That brings the total number of progressive multifocal leukoencephalopathy cases to 28 since July 2008.
Officials at the Cambridge, Mass.-based biotechnology company (Nasdaq: BIIB) say that even with the addition of four new cases between the end of October and the end of November, the risk of developing the infection is not higher than expected.
“The risk for patients taking the drug for less than a year is 0.4 per 1,000 and the risk for those taking it for more than two years is one in 1000, consistent with what it says on the label,” said Naomi Aoki, Biogen’s director of public affairs.
Since the risks increase the longer a patient takes the drug, the number of PML cases is expected to rise. A disproportionate share of the cases have been detected outside the U.S. Biogen officials believe a number of factors are at play in this trend, but that the relatively heavier use of other immunosuppressant treatments overseas may play a role.
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WALTHAM, Mass., Jan. 5 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.
The Pharmacor finding from the topic entitled Multiple Sclerosis reveals that, although oral cladribine's first-to-market advantage over FTY-720 will be reduced as a result of a likely delay to market caused by the FDA's action, oral cladribine is still expected to launch in the U.S. in 2010 while FTY-720 remains on track to launch in early 2011. Merck Serono, which has not released details about the contents of the letter that its U.S. affiliate EMD Serono received from the FDA in late 2009, has indicated that it is in discussions with the FDA regarding the resubmission of the new drug application for oral cladribine.
"Typically, the FDA will issue an RTF letter if some aspect of a new drug application is incomplete but this action is not a reflection of the FDA's opinion regarding a drug's efficacy or safety profiles," said Decision Resources Analyst Bethany Kiernan, Ph.D. "At this time, we assume the RTF letter will not significantly delay the 2010 launch of oral cladribine in the United States."
Scientists found mothers who were pregnant during the autumn and winter were most likely to give birth to those who would suffer from the debilitating neurological disease.
The researchers, based at Glasgow university and the city's Southern General Hospital, believe the spike in cases among children born in the spring may be due to a shortage of vitamin D because duing a vital developmental stage their mothers are exposed to less sunshine.
Vitamin D, which is largely gained through sunlight and food, is known to regulate a gene that can predispose individuals to MS. If the gene is passed on to the unborn child, without being regulated by a sufficient amount of vitamin D, it could "hard wire" them to develop the disease in later life.
The new study, published in the European Journal of Neurology, is the biggest yet carried out in Scotland, which has the highest rate of MS in the world.
MS affects about 85,000 people in the UK and 10,500 in Scotland. While the cause is not known, experts believe a combination of genetic and environmental factors are responsible for the condition.
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