Company Update (NASDAQ:AMGN): FDA Grants Priority Review for Amgen, Inc.’s Supplemental New Drug Application for Expanded Labeling of Kyprolis

Amgen, Inc. (NASDAQ:AMGN) announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis®(carfilzomib) for Injection for patients with relapsed multiple myeloma. The sNDA is designed to expand the current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy. The Prescription Drug User Fee Act (PDUFA) target action date is Jan. 22, 2016.

The FDA’s acceptance of this new sNDA for Kyprolis follows the recent FDA approval for Kyprolis in combination with Revlimid® (lenalidomide) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.

Multiple myeloma is a rare and complex blood cancer that has historically been one of the most difficult to treat diseases because of the inherent complexities related to the recurring pattern of remission and relapse. Patients face poor outcomes, which worsen with each relapse.

“Clinicians need a range of options and robust clinical data to make informed choices that can ideally extend the time patients live without their cancer progressing,” said Sean E. Harper, M.D., executive vice president of Research and Development atAmgen. “The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple myeloma and we look forward to working with the FDA over the coming months.”

The application is based on data from the Phase 3 head-to-head ENDEAVOR study, which showed that patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over bortezomib and low-dose dexamethasone (median progression-free survival [PFS] 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65; p<0.0001).

Treatment discontinuation due to adverse events and on-study deaths was comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the bortezomib arm. There was also an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to bortezomib in ENDEAVOR.

Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. (Original Source)

Shares of Amgen closed today at $150.59, down $3.32 or 2.16%. AMGN has a 1-year high of $181.81 and a 1-year low of $127.67. The stock’s 50-day moving average is $160.06 and its 200-day moving average is $159.38.

On the ratings front, Amgen has been the subject of a number of recent research reports. In a report issued on September 8, UBS analyst Matt Roden upgraded AMGN to Buy, with a price target of $168, which represents a potential upside of 11.2% from where the stock is currently trading. Separately, on September 2, Raymond James’ Christopher Raymond initiated coverage with a Hold rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Matt Roden and Christopher Raymond have a total average return of 32.5% and 46.9% respectively. Roden has a success rate of 83.7% and is ranked #61 out of 3771 analysts, while Raymond has a success rate of 83.3% and is ranked #22.

Overall, 3 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $189.20 which is 25.2% above where the stock opened today.


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