– Aranesp sales +11%
– Epogen sales -44%
– Neulasta sales +4%
– Enbrel sales +24%
– Sensipar/Mimpara sales +10%
The CEO says, “We are off to a strong start in 2016 delivering results for the year and laying groundwork for our long-term growth with innovative new product launches globally.”
More Amgen News
January 22, 2016: Amgen announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1 Repatha was developed in Japan by Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
Results from Phase 3 studies showed that adding Repatha to background lipid-lowering therapy that included statins resulted in intensive reductions in LDL-C. YUKAWA-2, a pivotal Phase 3 study in Japanese patients with high cardiovascular risk and high cholesterol, demonstrated that subcutaneous Repatha 140 mg every two weeks or 420 mg every four weeks, compared to placebo, in combination with daily doses of atorvastatin, reduced LDL-C by 67 to 76 percent from baseline at week 12 and at the mean of weeks 10 and 12. The adverse events that occurred in greater than 2 percent of the Repatha group were nasopharyngitis (16.8 percent Repatha; 17.8 percent placebo), gastroenteritis (3.0 percent Repatha; 1.0 percent placebo) and pharyngitis (2.5 percent Repatha; 2.5 percent placebo).3 Results from TAUSSIG, a global, open-label, single-arm study in patients with homozygous FH, including patients in Japan, showed Repatha reduced LDL-C by approximately 23 percent. The adverse events that occurred in greater than 5 percent of patients were nasopharyngitis (9.0 percent) and influenza (7.0 percent).
Repatha is also approved in the European Union, United States and Canada.
January 21, 2016: Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.
The approval is based on results from the Phase 3 head-to-head ENDEAVOR study. This was a superiority trial in which the primary endpoint was progression-free survival (PFS). The data showed patients with relapsed multiple myeloma treated with Kyprolis and dexamethasone achieved 50 percent greater PFS of 18.7 months compared to 9.4 months in those receiving Velcade(bortezomib) and dexamethasone, a current standard of care in relapsed multiple myeloma. Patients in the study were treated until disease progression.
The most common adverse reactions (greater than or equal to 20 percent) in the Kyprolis arm were anemia, diarrhea, dyspnea, fatigue, insomnia, pyrexia and thrombocytopenia.This new indication for Kyprolis is the second in six months. In July 2015, the FDA approved another expanded indication for Kyprolis in combination with lenalidomide and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
Amgen Inc (AMGN Updated Trend Analysis) is a biotechnology company that discovers, develops, manufactures, and delivers human therapeutics worldwide.
Amgen Science published this video about their science:
Amgen published one of the most enlightening educational videos on cancer available on YouTube. Here is Part 1:
Here is Part 2:
Here is Part 3:
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