Pfizer/Ligand Fablyn delayed
Executive Summary
FDA issues "complete response" letter for Pfizer/Ligand's osteoporosis drug Fablyn (lasofoxifene) Jan. 16. FDA has expressed concern with an apparent increase in mortality among Fablyn patients. FDA's Reproductive Health Drugs Advisory Committee found that trend to be inconclusive during a Sept. 8 meeting, and voted 9-3 (with one abstention) that there was a population of post-menopausal women with osteoporosis for which the use of Fablyn outweighed the risks (1"The Pink Sheet," Sept. 15, 2008, p. 3). Pfizer proposed a 50,000-patient post-marketing safety cohort study to help resolve the issue
You may also be interested in...
Fablyn Panel Finds Mortality Trend Inconclusive, But Pfizer Ready With A Plan
FDA's Advisory Committee for Reproductive Health Drugs did not reach a clear conclusion on whether Pfizer's osteoporosis drug Fablyn has a mortality issue - but Pfizer already has a proposal for a post-market study to provide a definitive answer
US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments
FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.
The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.