DBA-UK is pleased to announce the issuing of a new information sheet on Pregnancy in DBA, in conjunction with Dr. Sarah Ball, Reader/Hon Consultant in Paediatric Haematology St George's Hospital Medical School, London. We wish to point out that this is not designed to replace extensive discussions with a patients own consultant, it does, however, give an excellent starting point for those discussions.
The leaflet can be viewed here
The European Commission (EC) has granted approval for Exjade® (deferasirox) as a new treatment to help patients with transfusional iron overload in all 25 member states of the European Union (EU). Exjade was granted approval after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending marketing authorization. Additional regulatory submissions for Exjade have been made around the world.
A copy of the UK Press release is here and the European press release can be found here
Although Exjade is now licensed in the US, the European and UK licensing is not yet through. However, a few people are getting to try it in an expanded access study run by the company. It will be interesting to find out how they get on before it becomes widely available, because a high proportion of individuals on transfusion programmes are likely to want to change on to it. It should also provide valuable patient experience to make it easier to lobby PCTs about Exjade funding if there are any difficulties
DBA-UK is pleased to announce the issuing of a new patient information leaflet, along with a lo-call 0845 national information phone number. The leaflet is designed to be a first contact for newly diagnosed patients and their families. Alan Dewick, Information Officer said Too often newly diagnosed families find themselves with little or no information on the condition and its prognosis. Information that was previously available tended to be ad-hoc and based on 20 or 30 year old data. This leaflet will enable them to access the group and latest information on the condition.
The new national information phone number is 0845 094 1548. The group hopes to launch an 0845 Support line during 2006.
We have been invited to send a representative to the next meeting of this forum. It originally met in 2005 with the following aims -
Exjade has been approved, by the US Food and Drug Administration (USA - FDA), for the treatment of chronic iron overload due to blood transfusions in adults and children age two and older.
Novartis Press Release
Thanks to Mikey for this update
The phase IV paperwork is in the process of going through at the moment. When the trial starts it will be based in 3 UK centres London, Birmingham and possibly Manchester. Hopefully it should be out around September.
Exjade is an iron chelator administered as a drink (the tablets are dispersed in a glass of orange juice, apple juice or water), which compared to the current standard method of subcutaneous infusion lasting eight to 12 hours per night, for five to seven nights a week suddenly makes transfusion dependency a lot easier for those patients involved. Chelators are used by transfusion dependant patients to remove the iron overload caused by constant blood transfusions. More information is available from the Novartis web site
