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Setback for Amgen

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Amgen Inc. (AMGN) was recently dealt a blow by the US Food and Drug Administration (:FDA) when it halted the pediatric trials, evaluating the company’s drug Sensipar (cinacalcet hydrochloride), for safety reasons. Sensipar, a calcium-sensing receptor agonist, is already available for decreasing the release of parathyroid hormone (PTH) from the parathyroid gland in adults since 2004.

The FDA cleared Amgen’s drug for treating secondary hyperparathyroidism in adults with chronic kidney disease on dialysis. It is also approved for treating   hypercalcemia (excess calcium in the blood) in adults suffering from parathyroid cancer and severe hypercalcemia in adults with primary hyperparathyroidism, who are unable to undergo parathyroidectomy.
Amgen was conducting the studies to evaluate the efficacy and safety of Sensipar in patients less than 18 years of age. The FDA stopped the trials following the death of a 14-year-old patient.  The US regulatory body said that it is in the process of gathering information about the death. Even though the FDA is not fully sure that the death was caused by Sensipar, it stopped all pediatric studies on the drug as a safety measure.

We note this is not the first setback for Amgen this year. Earlier this month, Amgen, along with partner UCB (UCBJY), announced the decision to discontinue a phase III program being conducted with CDP7851/AMG785 (romosozumab) for the acceleration of fracture healing. UCB/Amgen’s decision was based on phase II data and regulatory guidance on fracture healing programs.  

Amgen currently carries a Zacks Rank #3 (Hold). Companies like Cytokinetics, incorporated (CYTK) and Alkermes (ALKS) currently look more attractive. While Cytokinetics carries a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank #2 (Buy).

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