FDA To Review Potential New Use Of XGEVA® (Denosumab)

Thousand Oaks, CA /PRNewswire/ – Amgen (NASDAQ: AMGN) now announced a U.S. Food and Drug Administration (FDA) has invited a Company to attend in a assembly of a Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to plead a supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to provide group with castration-resistant prostate cancer (CRPC) during high risk of building bone metastases.

The ODAC will examination formula from clinical studies in support of this new indication, including a pivotal ’147 trial, a randomized, placebo-controlled, multi-center Phase 3 investigate that compared XGEVA to remedy in prolonging bone metastasis-free participation in group with non-metastatic CRPC who were during high risk for bone metastases formed on prostate specific antigen criteria.

Amgen skeleton to plead a due sBLA with ODAC, to support a use of XGEVA in a diagnosis of group with non-metastatic CRPC; a studious race for whom there are no authorized treatments to check or forestall a widespread of cancer to bone.

The sBLA was submitted on Jun 27, 2011, and a Prescription Drug User Fee Act transformation date has been scheduled for Apr 26, 2012. If approved, this will be a second denote for XGEVA in a United States (U.S.).

About XGEVA
XGEVA is a initial and usually RANK Ligand inhibitor authorized by a FDA indicated for a impediment of skeletal-related events (SREs) in patients with bone metastases from plain tumors. XGEVA was primarily authorized following a 6 month priority examination by a FDA. XGEVA is not indicated for a impediment of SREs in patients with mixed myeloma. XGEVA is a initial novel bone metastases diagnosis for modernized cancer patients in scarcely a decade. Delivered as an each 4 week 120 mg subcutaneous injection, XGEVA provides a singular choice for urologists and oncologists to forestall SREs in patients with bone metastases from plain tumors.

XGEVA is a entirely tellurian monoclonal antibody that binds to RANK Ligand, a protein essential for a formation, avocation and participation of osteoclasts (the cells that mangle down bone). XGEVA prevents RANK Ligand from activating a receptor, RANK, on a aspect of osteoclasts, thereby dwindling bone destruction.

XGEVA has been complicated in over 7,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically suggestive alleviation compared to a before customary of caring in preventing bone complications. XGEVA is also being investigated for a intensity use to check a conflict of bone metastasis in adjuvant breast cancer.

XGEVA Important Safety Information
XGEVA can means critical hypocalcemia. Correct pre-existing hypocalcemia before to XGEVA treatment. Monitor calcium levels and discharge calcium, magnesium and vitamin D as necessary. Advise patients to hit a medical veteran for symptoms of hypocalcemia.

Osteonecrosis of a jaw (ONJ) can start in patients receiving XGEVA. Patients who are suspected of carrying or who rise ONJ while on XGEVA should accept caring by a dentist or an oral surgeon. In these patients, endless dental medicine to provide ONJ might intensify a condition.

The many common inauspicious reactions in patients receiving XGEVA were fatigue/asthenia, hypophosphatemia and nausea. The many common critical inauspicious greeting in patients receiving XGEVA was dyspnea. The many common inauspicious reactions ensuing in discontinuation of XGEVA were osteonecrosis and hypocalcemia. Please revisit www.amgen.com or www.xgeva.com for full U.S. prescribing information.

XGEVA Regulatory Status
XGEVA has been authorized in a U.S., Canada, a European Union (EU), Switzerland, Australia and Russia for a impediment of SREs in patients with bone metastases from plain tumors. XGEVA is not authorized to forestall SREs in patients with mixed myeloma.

Amgen has also submitted selling applications for XGEVA in Mexico, South Africa, Gulf Cooperation Council countries, Morocco, and Egypt. In Japan, Amgen is operative with a chartering partner, Daiichi Sankyo Company, Limited and a selling focus was submitted. In addition, Amgen and GlaxoSmithKline (GSK) have a partnership agreement for a commercialization of XGEVA in a series of countries where Amgen does not now have a blurb presence. In these countries, selling applications are filed by GSK.

Bone Metastases and SREs: Prevalence and Impact
Bone metastases start in some-more than 1.5 million patients with cancer worldwide and are many ordinarily compared with cancers of a prostate, lung, and breast, with occurrence rates as high as 90 percent of patients with metastatic disease. [i] [ii] [iii] [iv]

Approximately 50-70 percent of cancer patients with bone metastases will knowledge debilitating SREs.[v] [vi] [vii] Events deliberate to be SREs embody fractures, spinal cord compression, and critical bone pain that might need medicine or radiation. [viii] Such events can profoundly interrupt a patient’s life and can means incapacity and pain. [ix] [x] [xi]

Denosumab and Amgen’s Research in Bone Biology
The denosumab growth module demonstrates Amgen’s joining to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is investigate denosumab in countless growth forms opposite a spectrum of cancer-related bone diseases. Over 11,000 patients have been enrolled in a denosumab oncology clinical trials. In further to a impediment of SREs, XGEVA is also being evaluated for a intensity to check bone metastases in adjuvant breast cancer.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative tellurian therapeutics. A biotechnology colonize given 1980, Amgen was one of a initial companies to comprehend a new science’s pledge by bringing protected and effective medicines from lab, to production plant, to patient. Amgen therapeutics have altered a use of medicine, assisting millions of people around a universe in a quarrel opposite cancer, kidney disease, rheumatoid arthritis, bone illness and other critical illnesses. With a low and extended tube of intensity new medicines, Amgen stays committed to advancing scholarship to dramatically urge people’s lives. To learn some-more about a pioneering scholarship and a critical medicines, revisit www.amgen.com. Follow us on www.twitter.com/amgen.

Forward Looking Statements
This news recover contains forward-looking statements that are formed on management’s stream expectations and beliefs and are theme to a series of risks, uncertainties and assumptions that could means tangible formula to differ materially from those described. All statements, other than statements of chronological fact, are statements that could be deemed forward-looking statements, including estimates of revenues, handling margins, collateral expenditures, cash, other financial metrics, approaching legal, arbitration, political, regulatory or clinical formula or practices, patron and prescriber patterns or practices, payment activities and outcomes and other such estimates and results. Forward-looking statements engage poignant risks and uncertainties, including those discussed next and some-more entirely described in a Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s many new annual news on Form 10-K and many new periodic reports on Form 10-Q and Form 8-K. Please impute to Amgen’s many new Forms 10-K, 10-Q and 8-K for additional information on a uncertainties and risk factors compared to a business. Unless differently noted, Amgen is providing this information as of Dec. 29, 2011 and specifically disclaims any avocation to refurbish information contained in this news release.

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[i] Tannock IF, Wit R, Berry WR, Horti J, Pluzanska A, Chi K, et al. Docetaxel and prednisone or mitoxantrone and prednisone for modernized prostate cancer. N Engl J Med. 2004;351(15):1502-12.

[ii] Petrylak DP, Tangen CM, Hussain MH, Lara PN, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for modernized adverse prostate cancer. N Engl J Med. 2004;351(15):1513-1520.

[iii] Prostate cancer clinical hearing finish points: ”RECIST”ing a step backwards. American Association for Cancer Research website. clincancerres.aacrjournals.org. Accessed on Feb 16, 2011.

[iv] Coleman RE. Skeletal complications of malignancy. Cancer. 1997; 80(suppl): 1588-1594.

[v] Lipton A, Theriault RL, Hortobagyi GN. Pamidronate prevents fundamental complications and is effective palliative diagnosis in women with breast carcinoma and osteolytic bone metastases. Cancer. 2000;88:1082-1090.

[vi] Saad F, Lipton A, Cook R, Chen YM, Smith M, Coleman R. Pathologic fractures correlated with reduced participation in patients with virulent bone disease. Cancer. 2007;110:1860-1867.

[vii] Rosen LS, Gordon D, Tchekmedyian NS, et al. Nonsmall dungeon lung carcinoma and other plain tumors. Cancer. 2004;100:2613-2621.

[viii] Costa L, Badia X, Chow E, Lipton A, Wardley A. Impact of fundamental complications on patients’ peculiarity of life, mobility, and organic independence. Support Care Cancer. 2008; 16: 879-889.

[ix] Norgaard M, Jensen AO, Jacobsen JB, Cetin K, Fryzek JP, Sorensen HT. Skeletal compared events, bone metastasis and participation of prostate cancer: a race formed conspirator investigate in Denmark (1999 to 2007).J Urol. 2010; 184:162-167.

[x] Johnell O, Kanis JA. An guess of a worldwide superiority and incapacity compared with osteoporotic fractures. Osteoporos In.t 2006;17:1726–1733.

[xi] Saad F, Gleason DM, Murray R, et al. A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory MetastaticProstate Carcinoma. Journal Ntl Cancer Inst. 2002;19:1458-1468.

SOURCE Amgen

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