New Once-Daily Advagraf Launched Across Europe - New Formulation Provides A More Convenient Dosing Option For Organ Transplant Recipients

Main Category: Transplants / Organ Donations
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 03 Oct 2007 - 4:00 PDT

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The EU-wide availability of the immunosuppressant Advagraf® (tacrolimus, prolonged release) is likely to bring greater convenience to patients who have had an organ transplant, announced Astellas at the 13th Congress of the European Society for Organ Transplantation in Prague.

As the first calcineurin inhibitor (CNI) with a once-daily dosing option, Advagraf® has the potential to help improve clinical outcomes by improving adherence. Research has shown that once-daily medication more than doubles the likelihood of patients taking their medication as prescribed when compared to twice daily dosing.

"A once-daily dosing option for a cornerstone CNI immunosuppressant is great news for both patients and physicians, and is a big step forward in addressing the growing concern of nonadherence," explained Professor Rutger Ploeg, Secretary General, ESOT. "The current donor organ shortage crisis in the EU means that anything that will help reduce the risk of serious medical consequences associated with nonadherence in transplant recipients is most welcome."

Most organ transplant recipients are on multiple drug regimens, which make life-long adherence a major challenge. Research suggests 20% to 50% of organ transplant patients fail to take their medications correctly, putting themselves at risk of medical consequences.

Missing just a few doses of their cornerstone immunosuppressant therapy can put transplant recipients at risk of late acute graft rejection, posing a threat to the survival of the graft.

Carel Boullart is a sporty 63-year old man living in The Netherlands, who had a kidney transplant seven years ago. He used to take twice-daily Prograf® (tacrolimus) and welcomed the opportunity to switch to once-daily Advagraf® two years ago as part of a clinical trial programme. "I lead an active life, riding my bike and playing golf whenever possible. I think once-daily is much more convenient than twice daily - I take my medication every morning one hour before my breakfast - with one dose a day, you can't forget to take it," Carel adds.

About Advagraf®

Advagraf® is a once-daily formulation of Prograf® (tacrolimus, twice-daily formulation), a leading immunosuppressive agent of care in the prevention of organ rejection, developed by Astellas. Advagraf® has been approved in the European Union for the prophylaxis of transplant rejection (primary and maintenance therapy) in adult kidney or liver allograft recipients and for the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products drugs in adult patients.

Advagraf® is already available in the UK & Germany and it is anticipated that Advagraf® will be launched in around 10 more EU countries before the end of this year.

About Astellas

Astellas Pharma Europe Limited, located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organisation is committed to becoming a global category leader by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. In Europe, Astellas markets products in the areas of Immunology, Urology and Dermatology. Astellas Pharma Europe is responsible for 19 affiliate offices located across Europe, the Middle East and Africa, 2 R&D establishments and 3 manufacturing plants with approximately 3,300 staff.

- Weng, FL., Israni, AK., Joffe, MM., et al. Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol 2005; 16(6): 1839-1848

- Laederach-Hofman, K. Bunzel, B. Noncompliance in organ transplant recipients: a literature review. Gen Hosp Psychiatry 2000; 22(6): 412-424.

- Denhaerynck, K., Dobbels, F., Cleemput, I. et al. Prevalence, consequences and determinants of nonadherence in adult renal transplant patients: a literature review. Transplant International 2005; 13: 1121-1133

http://www.astellas-europe.co.uk/