Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 246 entries as of 7/8/09. 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 BioMedReports.com, 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 clinical trial results.
On 7/8/09, Bayer (ETR:BAY) (OTC:BAYRY) announced the submission of a New Drug Application (NDA) to the FDA for a new estradiol-based oral contraceptive (estradiol valerate/dienogest). It seeks approval for the indications oral contraception and treatment of heavy and/or prolonged menstrual bleeding. The new product with an estradiol valerate/dienogest combination is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. It is marketed in Europe under the tradename Qlaira. The estimated PDUFA action date for a standard, 10-month review by the FDA for this NDA is 5/8/10.
Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen's experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.
On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.
On 7/8/09, Biogen Idec (NASDAQ:BIIB) announced that the FDA granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS).
