ZarnestraTreatment for Acute Myeloid Leukemia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data
RARITAN, N.J., June 30, 2005, 2005 -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) for the tipifarnib new drug application (NDA), which was based on data from a single Phase II study. Tipifarnib is an oral medication studied to treat acute myeloid leukemia (AML) in elderly patients who are not candidates for standard chemotherapy. The not approvable letter explains why the NDA cannot be approved based on currently submitted data.
The company remains committed to the development of tipifarnib. Recognizing the unmet medical need in this area, the company is reviewing the FDA's letter and will determine appropriate next steps.
J&JPRD completed the submission of the tipifarnib NDA to the FDA under the Continuous Marketing Application Pilot-1 Program in December 2004, and the application was discussed at a May 5, 2005 Oncology Drugs Advisory Committee meeting. As a drug intended to treat a life-threatening disease for which there is an unmet medical need, tipifarnib was granted "Fast Track" status by the FDA in June 2004. Tipifarnib also was granted Orphan Drug status, a designation given to medications used to treat a rare disease or condition.
AML is a rare but often fatal cancer that will impact nearly 12,000 Americans in 2005.
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is part of the Johnson & Johnson Family of Companies, the world's most broadly-based producer of healthcare products. J&JPRD, with its headquarters in Raritan, N.J., has eleven sites throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. Combining innovation and experience, the company's major therapeutic areas of focus include hematology, oncology, infectious disease, neurology and psychiatry, pain and women's health.
Source: Johnson & Johnson
Posted: June 2005
- Johnson & Johnson Completes Submission of Tipifarnib NDA to FDA - January 24, 2005
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.