FDA Calendar Updates: Acorda, Amgen, DOR BioPharma Print E-mail
Tuesday, 04 August 2009 12:13

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 290 entries as of 8/4/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.


On 7/1/09, Acorda Therapeutics (NASDAQ:ACOR) announced an exclusive deal with Biogen Idec (NASDAQ:BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales. The FDA is currently reviewing a New Drug Application (NDA) for Fampridine-SR with a Priority Review (six-month) designation and a PDUFA action date during mid-4Q09 for a possible FDA decision.

On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS) in response to a Refuse to File letter for the NDA on 3/30/09. On 5/6/09, the FDA accepted the NDA with a priority review designation and PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS. On 8/4/09, ACOR announced that a Peripheral and Central Nervous System Drugs FDA Advisory Committee meeting will be held to review Fampridine-SR, with the date to be announced. ACOR also provided an update of adverse events (AE) for its three key MS studies with the only new AE being MS relapse (at 5.3% for the Fampridine-SR treated group vs. 3.8% for placebo). The imbalance for this AE was due to worsening of MS symptoms occurring after discontinuation of the drug.

On 8/4/09, DOR BioPharma (DORB.OB) announced that the FDA granted Orphan Drug Designation to Oral BDP (beclomethasone 17,21-dipropionate or orBec) for the treatment of gastrointestinal symptoms associated with chronic Graft-versus-Host disease (cGVHD) in patients who have undergone allogeneic hematopoietic cell transplantation. orBec is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. orBec and oral BDP are currently in development by DOR for the treatment and prevention of GVHD, the prevention of acute radiation enteritis and the treatment of Crohn's disease. The upcoming confirmatory Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multi-center trial and will seek to enroll an estimated 166 patients with patient enrollment expected to begin during 2H09. The primary endpoint is the treatment failure rate at Study Day 80 (this endpoint was successfully measured as a secondary endpoint in the previous Phase 3).

On 6/9/09, DORB.OB announced that it received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of this pivotal study. The EMEA agreed that should the new confirmatory Phase 3 study produce positive results, the data would be sufficient to support a marketing authorization approval in all 27 European Union (EU) member states, which is consistent with feedback previously received from FDA, which includes an agreement on the design of the upcoming Phase 3 study via the Special Protocol Assessment (SPA) procedure. The SPA procedure is an agreement with the FDA that the Phase 3 study design is acceptable to support a regulatory submission seeking new drug approval.

On 8/3/09, Amgen (NASDAQ:AMGN) announced positive top-line results from a pivotal Phase 3 head-to-head trial evaluating denosumab administered subcutaneously versus Zometa (zoledronic acid) administered as an intravenous (IV) infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.

For the primary endpoint, patients treated with denosumab experienced a similar time to first skeletal-related event (SRE) (fracture, radiation to bone, surgery to bone, or spinal cord compression) compared with those receiving Zometa (hazard ratio 0.84, 95 percent CI: 0.71-0.98), which is statistically significant for non-inferiority (p<0.0007). Although numerically greater, the delay in the time to first SRE associated with denosumab treatment was not statistically superior compared to Zometa (adjusted p=0.06) (secondary endpoint). The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95 percent CI: 0.77-1.04) (secondary endpoint).

Overall, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for these two agents. Rates of osteonecrosis of the jaw (ONJ) were balanced and infrequent in both treatment groups (10 patients receiving denosumab as compared with 11 patients receiving Zometa). Infectious adverse events were balanced between the two treatment arms, as was overall survival and the time to cancer progression.

AMGN has a pending BLA for denosumab with a PDUFA action date during mid-4Q09 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 reviewed 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. On 7/27/09, AMGN and Glaxo (NYSE:GSK) announced a deal to share commercialization of denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico. On 8/3/09, AMGN announced positive top-line results from a pivotal Phase 3 head-to-head trial (the second of three pivotal studies) evaluating denosumab administered subcutaneously versus Zometa administered as an IV infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.

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