Namenda "not approvable" for mild-moderate Alzheimer’s
This article was originally published in Pharmaceutical Approvals Monthly
Forest's Namenda (memantine) is "not approvable" for treatment of mild-to-moderate Alzheimer's disease, the firm says July 25. Two studies failing to show statistical significance led FDA to deny the indication. The sNDA included a third study showing statistical significance, but "FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies," Forest said. Namenda would have been the first AD agent approved for the full continuum of the disease. J&J's Risperdal (risperidone) also was deemed not approvable recently for an Alzheimer's-related indication (1Pharmaceutical Approvals Monthly June 2005, p. 13)...
You may also be interested in...
Johnson & Johnson is considering how to proceed with Risperdalafter two supplemental applications for new indications for the atypical antipsychotic have been deemed "not approvable" by FDA
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.