Johnson & Johnson Pharmaceutical Research & Development, L.L.C., has completed the submission of a New Drug Application (NDA) for tipifarnib, an investigational cancer drug, to the US FDA Continuous Marketing Application (CMA) Pilot-1 Programme.
Tipifarnib, administered orally, is being investigated in patients with 65 years of age and older with newly diagnosed acute myeloid leukaemia (AML).
As a drug intended to treat a life-threatening disease for which there is an unmet medical need, tipifarnib (R115777) was granted "Fast Track" status by the FDA in June 2004. The company has submitted the tipifarnib NDA based on phase II clinical data, which uses measurements of activity or responsiveness of a disease to the treatment rather than survival endpoints. In October 2004, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., initiated a phase III study to fully demonstrate the clinical benefit of tipifarnib in this condition.
Under the CMA Pilot-1 Programme, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., submitted reviewable units of the tipifarnib NDA as they were completed, receiving ongoing feedback from the FDA. The standard FDA review time for the CMA Pilot-1 Programme is six months following submission of the final reviewable unit. Tipifarnib also was granted Orphan Drug status, a designation given to medications used to treat a rare disease or condition.
If approved, tipifarnib will be marketed in the United States by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., will seek approval from regulatory authorities around the world for tipifarnib.