Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
On 6/8/09, Micromet (NASDAQ:MITI) announced the presentation of Phase 2 clinical data of the BiTE® antibody blinatumomab (MT103), which showed a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease. Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells. The patients included in this Phase 2 study were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow -- so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD. Currently, 13 of 16 (81% of evaluated patients) have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study and MITI will discuss a pivotal ALL program with regulatory authorities later in the year.
On 6/8/09, Keryx Biopharma (NASDAQ:KERX) announced results of its Phase 2 study of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on thrice weekly hemodialysis. The top line efficacy and safety results from this Phase 2 study were submitted to the FDA, and discussed at a recent face to face meeting with the Division of Cardiovascular and Renal Drug Products. The FDA also reviewed the final reports for the 90-day rat and 16-week canine toxicology studies. The FDA indicated that the results of the Phase 2 study and the toxicology studies were adequate to support entry into a Phase 3 program. Keryx is in the process of finalizing the Phase 3 program in consultation with the FDA.
On 6/7/09, GlaxoSmithKline (NYSE:GSK) announced new Phase 2 clinical trial data demonstrating that the Company's investigational type 2 diabetes treatment Syncria (albiglutide) significantly reduced blood glucose levels and provided weight loss across weekly, bi-weekly and monthly dosing. In the study, dose-dependent reductions in A1C (a measure of how well blood sugar is being controlled over time) with albiglutide 30 mg weekly, 50 mg bi-weekly, and 100 mg monthly were 0.9%, 0.8% and 0.9% respectively. The A1C reduction by placebo was 0.2% and by open-label exenatide (marketed as Byetta) was 0.5%. Weight loss (0.9 to 1.8 kg) was observed across all doses. The most frequently reported adverse events included nausea, vomiting and headache.
At the 30 mg weekly dose, fewer than 10% of patients experienced nausea and vomiting, which subsided after week eight. GLP-1 is a peptide that acts throughout the body to help maintain normal blood sugar levels and to control appetite. Albiglutide is the only medication which fuses modified human GLP-1 to human albumin so that it has an extended duration of action that allows for weekly or even less frequent injections. The Phase 3 clinical development program for albiglutide (evaluating the 30mg weekly dose) began with five studies in early 2009 and is expected to last 2-3 years.
On 6/8/09, Dyax Corp. (NASDAQ:DYAX) announced today that the FDA accepted the Company’s submission in response to the FDA’s March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax’s BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09.
Shares of Arena Pharma (NASDAQ:ARNA) climbed higher by about 25% on Monday after the Company said its obesity drug candidate lorcaserin helped patients lose and keep off weight in a clinical trial. Arena said patients who took lorcaserin had "highly significant" weight loss in their first year, and they were more likely to maintain the weight loss in their second year than those who took a placebo. The Company, which announced the results at the American Diabetes Association conference in New Orleans, said lorcaserin patients fared better in terms of cardiovascular risk, and the drug was not associated with heart valve problems or depression.
Meanwhile, Progenics Pharma (NASDAQ:PGNX) announced that its collaborator, Ono Pharmaceutical Co., Ltd. in Osaka, Japan, has begun clinical testing in Japan of Relistor (methylnaltrexone) subcutaneous injection, the first-in-class medicine approved in the U.S., Canada, the European Union, Australia and Latin American countries for the treatment of opioid-induced constipation. PGNX also announced the discontinuation of development for PRO 206, a pre-clinical compound for the treatment of hepatitis C virus (HCV) infection, in line with its ongoing initiative to allocate resources to the most important programs in order to increase operating efficiencies, and that it will instead focus on its second-generation HCV-entry inhibitor portfolio, anticipating selection of a new development candidate in 2010.
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