Playing Catch-up

J0423022 I took last week off for the holidays.  Expecting guests, planning menus and my other regular duties left no time for posting and I suspected, little time for others to be reading.  However, in spite of the holidays, things did happen, so I thought it would be good to review some of the more interesting things that transpired. 

  • New Prostate Cancer Recommended for Approval in Europe – The Committee for Medicinal Products for Human Use (CHMP) recommends granting marketing authorization for Ferring Pharmaceutical's FIRMAGON┬« (degarelix)for treatment of prostate cancer.  Ferring Pharmaceuticals received notification on December 18 that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), has adopted a positive opinion and is recommending to grant a marketing authorization for FIRMAGON┬« (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer after demonstrating rapid, long-term suppression of testosterone.
  • Also in Europe, Celgene Gets An Approval – The European Commission granted VIDAZA(R) full marketing authorization for the treatment of patients with higher-risk Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML).  "The European Commission approval of VIDAZA is recognition of the significant survival benefit afforded by this therapy for critical hematologic malignancies," said Philippe Van Holle, President of Celgene Europe. "We will now begin working with local regulatory authorities on a country-by-country basis for reimbursement and distribution for all European Union member states."

  • Amgen Submits BLA for FDA Approval of Denosumab - On the 19th, Amgen announced that it has submitted a BLA for this biologic osteoporosis investigational treatment.  The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six Phase 3 trials involving more than 11,000 patients.  Look for a decision by next October 19th or so.

  • AstraZenecaGets Coal in Stocking from FDA on Christmas Eve for Seroquel XR for Major Depressive OrderThe press release from AstraZeneca about the receipt of a Complete Response Letter from FDA for Seroquel XRwas quite mum about the contents of the letter.  The letter failed to state any details about the nature of the FDA reservations over the NDA and did not say whether or not there would be new studies.  The day before the letter was issued, Teva announced that it had received tentative approval for the production of generic Seroquel

Coming up – I will update the graph of Complete Response Letters and approvals since August for the year end and will have some other look-backs as well as looks-forward. 

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