Featured Company News – Amgen Submits Regulatory Applications in US, Europe to Include Overall Survival Data in KYPROLIS Label
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LONDON, UK / ACCESSWIRE / July 18, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Amgen Inc. (NASDAQ: AMGN), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=AMGN. The Company announced on July 14, 2017, that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase-3 head-to-head ENDEAVOR trial in the product information for KYPROLIS® (carfilzomib). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Data submitted to regulatory authorities showed that KYPROLIS, when administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone (Kd56), reduced the risk of death by 21% and increased overall survival by 7.6 months compared to Velcade® (bortezomib) and dexamethasone (Vd).
About KYPROLIS
KYPROLIS is administered to patients suffering from relapsed myeloma, or if myeloma has become resistant to another treatment. KYPROLIS has been prescribed to more than 50,000 patients worldwide, since its approval in 2012. In this updated analysis, the adverse events observed were consistent with those previously reported for ENDEAVOR. The most common adverse events included anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, back pain, thrombocytopenia, and headache.
Sean E. Harper, M.D., Executive Vice President of Research and Development at Amgen, stated:
"KYPROLIS is the first and only multiple myeloma therapy to demonstrate superior overall survival in a head-to-head comparison with a current standard of care, extending survival by 7.6 months over Velcade. We submitted these important data to regulatory authorities in the US and Europe because we know that KYPROLIS may offer appropriate multiple myeloma patients a better chance for a longer life at first relapse compared to Velcade when added to dexamethasone."
KYPROLIS is approved in the US for the treatment of patients with relapsed or refractory multiple myeloma, who have received one to three lines of therapy, either as a single agent or in combination with dexamethasone or with lenalidomide plus dexamethasone.
KYPROLIS is also approved in other countries including Argentina, Australia, Bahrain, Canada, Hong Kong, Israel, Japan, Kuwait, Lebanon, Macao, Mexico, Colombia, Thailand, Turkey, Colombia, S. Korea, Canada, Qatar, Switzerland, UAE, Russia, Brazil, India, Oman, and the European Union.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. It is a rare and very aggressive disease that accounts for approximately one percent of all cancers. In the US, there are nearly 95,000 people living with, or in remission from, multiple myeloma.
About ENDEAVOR
The ENDEAVOR trial randomized 929 patients with relapsed myeloma, whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens, evaluated Kd56 versus Vd in those patients. The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death.
About Amgen
Founded in 1980, Amgen (formerly known as Applied Molecular Genetics Inc.) is one of the leading independent biotechnological companies. The Company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Amgen offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience. The Company is headquartered in Thousand Oaks, United States, and has its presence in approximately 100 countries worldwide.
Last Close Stock Review
At the closing bell, on Monday, July 17, 2017, Amgen's stock rose slightly by 0.15%, ending the trading session at $177.40. A total volume of 2.66 million shares has exchanged hands. The Company's stock price surged 9.43% in the last three months, 13.63% in the past six months, and 8.65% in the previous twelve months. Moreover, the stock rallied 21.33% since the start of the year. The stock is trading at a PE ratio of 16.81 and has a dividend yield of 2.59%. The stock currently has a market cap of $130.74 billion.
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