Phase III Trials for New MS Drug Daclizumab
posted by Paul Fiddian | 24.06.2010
Phase III trials of a new multiple sclerosis drug have now got underway, it was announced on 24 June 2010.
Daclizumab is the product of a Pharma industry tie-up between Abbott Laboratories and biotechnology firm Biogen Idec and the new round of trials will involve 1,500 patients from around the world.
Multiple sclerosis is a debilitating neurological condition and its symptoms include spells of dizziness, impaired vision, loss of cognitive ability and recollection and extreme fatigue. Up to 2.5 million people are thought to be affected by MS, the onset of which takes place when the immune system turns on the central nervous system.
No drug presently exists that can cure patients of MS, but it can be managed and the medical community is heavily involved in trying to develop new multiple sclerosis drug treatments in this vein.
Daclizumab Phase III Trials
Enrolment took place for the first selected Daclizumab Phase III trial patient in May and – according to analysts – providing the outcome is positive - the new drug could be submitted for approval by the US Food and Drug Administration (FDA) in around 2013/14. This approval given, Daclizumab could potentially then enter the marketplace.
“Despite significant advances in MS therapy, many patients continue to experience disease activity”, Ludwig Kappos – an MS researcher who’s involved in Daclizumab’s development, commented, adding: “The MS community is eager for new treatment approaches.”
Multiple Sclerosis Drug Treatments
Multiple Sclerosis patients can already get one Biogen-made MS treatment drug – Tysabri. However, this has been associated with PML - Progressive Multifocal Leukoencephalopathy: a disease that can ultimately kill. Figures issued by Biogen state that 55 people taking the drug have developed this condition of the 68,000 that have been prescribed it, and that 11 fatalities have been recorded to date.
As far as Daclizumab is concerned, no link with PML has so far been established.
Pharma News will present further coverage of Daclizumab’s progress towards FDA approval in future News Items.