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Pharmacyclics, Inc. Message Board

  • wedgemahalo wedgemahalo Jul 26, 2013 11:53 AM Flag

    Impact of early approval is HUGE!!

    See Bloomberg article from yesterday on J&J drug and getting to market two years early. The FDA is giving them ideas on how to get it to market faster!!!!!

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    • Johnson & Johnson (JNJ) and Pharmacyclics Inc. (PCYC) may push their experimental cancer drug to market two years faster than projected after gaining a new status the government now grants promising therapies.
      Pharmacyclics sent an application for review for ibrutinib to the Food and Drug Administration on July 10 to treat two blood cancers, which the agency may decide on by March 10. This is two years ahead of schedule after the FDA in February named ibrutinib a breakthrough therapy, said Jay Siegel, J&J’s head of global regulatory affairs. Such a designation prioritizes a drug’s development among agency staff.
      J&J may seek more breakthrough designations for ibrutinib as it studies the therapy for other uses, Siegel said in an interview in Washington. The FDA gained the power to grant the status in legislation passed a year ago and began issuing the classification in January.
      “This has had an enormous impact,” Siegel said during a congressional briefing yesterday on the new-drug designation. “There is a very proactive role on the part of the FDA. They’ll pick up the phone and call us and say ‘Have you thought of this way to do this faster? Have you thought about this problem?’”
      The FDA suggested some avenues the companies should take to seek approval that they hadn’t thought of, Siegel said, without being specific. The agency also helped J&J and Sunnyvale, California-based Pharmacyclics determine which trials must be done before submitting an approval application and which could be conducted after potential approval, he said.
      Clinical Trials
      The companies based the application on the second of what are typically three phases of clinical trials. J&J, the world’s biggest maker of health-care products, is based in New Brunswick, New Jersey.
      FDA inspectors who check quality at drugmakers’ facilities before drug approval and manufacturing compliance workers at the agency also have been working with the companies to help ibrutinib through the process. Scheduling agency inspections of overseas factories, which tend to take a long time, may prove a stumbling block for breakthrough-drug approvals, Siegel said.
      Ibrutinib has been assigned as a breakthrough designation for mantle cell lymphoma, chronic lymphocytic leukemia/small cell lymphoma and another rare lymphoma. The companies have applied to market the drug for use against mantle cell lymphoma and chronic lymphocytic leukemia/small cell lymphoma.

      Sentiment: Strong Buy

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