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Seattle Genetics, Inc. Message Board

  • timmo1958 timmo1958 Sep 19, 2013 1:33 PM Flag

    Orphan Drug Status for Adcetris for T Cell Lymphoma

    Good news... Came in at 10:03 pst. We'll see if stock moves. Any ideas? Best, Timmo

    Sentiment: Buy

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    • It's been designated but not approved.

      • 1 Reply to scr20022000
      • Still, an important development. From the FDA website:

        Designating an Orphan Product: Drugs and Biological Products

        The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.

        A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

    • This appears to be true, according to the FDA website. Look for SGEN's crack public relations team to issue a press release...possibly during your lifetime.
      brentuximab vedotin
      Trade Name: Adcetris
      Date Designated: 09-13-2013
      Orphan Designation: Treatment of patients with angioimmunoblastic T-cell lymphoma
      Orphan Designation Status: Designated
      FDA Orphan Approval Status: Not FDA Approved for Orphan Indication

 
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