Affymax, Inc. (Nasdaq:AFFY) today fronted the FDA Oncologic Drugs Advisory Committee (ODAC) where its New Drug Application (NDA) of peginesatide for the proposed treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis was reviewed. The panel was asked to consider the following question, “Considering the safety issues associated with other agents used to treat the anemia due to CKD, is there a favorable benefit/risk profile for peginesatide for use in patients who are on dialysis?”
The panel voted 15-1 in favour with one abstaining. Those in favour cited that peginesatide had demonstrated sufficient benefit for the dialysis population and were impressed with the sponsor’s presentation despite safety concerns showing a higher rate of cardiovascular events in patients who were were not on dialysis. One member of the panel, Dr Steven Nissen, noted concerns about bias in not blinding the trials. Those on the panel hoped that the labeling would reflect the population that was treated and suggested a post-marketing study to be conducted. While not bound by today’s positive recommendation, the FDA generally follows the advice of the advisory committee when deciding whether to approve or not. The PDUFA date is March 27, 2012.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) will be fronting the Psychopharmacologic Drugs Advisory Committee (PDAC) on December 12, 2011, at which the ADASUVE New Drug Application (NDA) will be discussed. The briefing documents can be found HERE. The FDA will be asking the committee to provide advice on the following:
“Has Staccato Loxapine for Inhalation been shown to be sufficiently effective as a treatment for agitation in patients with schizophrenia or bipolar mania, given its unique risks, and has it been shown to be reasonably safe for use in this context, when used in conjunction with the REMS that has been proposed by the sponsor, to justify its approval?”
Exelixis, Inc. (NASDAQ:EXEL) today reported preliminary data from its cabozantinib Phase 2 trial in patients with metastatic breast cancer (MBC). As of the October 15, 2011 data cut-off, 45 patients with previously treated estrogen receptor-positive, triple negative, or inflammatory MBC were enrolled in this cohort of the RDT and received cabozantinib at 100 mg per day. Tumor response was evaluated by modified RECIST in 44 evaluable patients with measurable disease and at least 12 weeks of follow up, of which 6 (14%) had a confirmed partial response (PR), 26 (59%) had stable disease (SD), and 9 (20%) had progressive disease (PD). The Week 12 disease control rate (week 12 SD or PR) was 48%.
DARA BioSciences, Inc. (Nasdaq:DARA) reported that Richard A. Franco, Sr. will retire as Chairman, President and Chief Executive Officer and as a director effective as of December 16, 2011. David J. Drutz, M.D., who is currently a member of the company’s board of directors, has been appointed to serve as an Interim Chief Executive Officer.