FDA Approves New Dose for Wyeth Transplant Drug
Posted on: Monday, 5 February 2007, 09:00 CST
The FDA has approved new dosing recommendations for Wyeth's drug Rapamune for high immunologic risk renal transplant recipients.
Rapamune is the only kidney transplant therapeutic with dosing recommendations specifically for the treatment of high immunologic risk renal transplant recipients. In high immunologic risk patients, it is recommended that a Rapamune-based regimen be used in combination with cyclosporine (CsA) and corticosteroids for the first year following transplantation. The new dosing recommendations also allow for use in combination with antibody induction therapy in this population.
High immunologic risk patients have a greater likelihood of developing acute rejection than low to moderate risk kidney transplant recipients. High immunologic risk patients are defined as transplant recipients who are black, repeat renal transplant recipients and patients with high-panel reactive antibodies (PRA).
The new labeling was based on clinical data indicating that a Rapamune-based regimen, when initiated post-transplant in combination with CsA, is efficacious in preventing acute rejection in high immunologic risk renal transplant recipients.
Source: Datamonitor
Related Articles
- Affymax Announces New Data Presented on the Long-Term Safety and Effectiveness of Hematide(TM) to Treat Anemia in Chronic Renal Failure Patients With Monthly Dosing
- FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated With Omeprazole and NEXIUM(R) (Esomeprazole Magnesium)
- Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks
- The Lancet Publishes PREVAIL Study Results Showing Lovenox(R) Superiority Over Unfractionated Heparin for Reducing the Risk of Venous ThromboEmbolism in Patients With Acute Ischemic Stroke
- Peregrine Announces Completion of Planned Patient Enrollment and Dosing in Initial Tarvacin(TM) Anti-Viral Hepatitis C Phase 1 Trial
- A Phase I Trial Combining High-Dose ^Sup 90^Y-Labeled Humanized Anti- CEA Monoclonal Antibody With Doxorubicin and Peripheral Blood Stem Cell Rescue in Advanced Medullary Thyroid Cancer
- Life-Threatening Abdominal Wall Hematoma in a Chronic Renal Failure Patient After a Single Dose of Enoxaparin
- The Effect of Irbesartan in Reducing Cardiovascular Risk in Hypertensive Type 2 Diabetic Patients: an Observational Study in 16 600 Patients in Primary Care
- Use of Aspirin to Reduce Risks of Cardiovascular Disease in Patients With Diabetes
- New Data Show Tamiflu May Reduce Risk of Pneumonia in Flu Patients
User Comments (0)
RSS Feeds