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BioCryst Pharmaceuticals, Inc. Message Board

  • maphere maphere Jan 29, 2013 5:14 PM Flag

    Approval on modest results...

    HHS has the IV P data, BCRX has completed their work (minus some sub analysis).

    If HHS / BARDA recommend BCRX to file an NDA will they get a similar approval as the following:
    ______________

    Jan. 29, 2013

    Last week FDA staffers came up with a lukewarm review of the efficacy seen in Boehringer Ingelheim's prospective COPD drug olodaterol, but couldn't fault its safety profile. And that seemed to satisfy the panel of outside experts who met to review the drug today, giving it a pass with a lopsided 15 to 1 vote in favor of approval.
    _______________

    We already know IDSA would like IV P approved based on non-inferiority to existing antivirals which is what Shionogi approval was about.

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    • Now for the rest of this 3 paragraph story ..deliberately left out..

      "We at Boehringer Ingelheim are pleased with the advisory committee's recommendation and look forward to continuing to work with the FDA as the agency continues its review of the olodaterol NDA," said Tunde Otulana, the vice president of clinical development and medical affairs, respiratory, for Boehringer Ingelheim Pharmaceuticals.

      another sad attempt to pump the flu.

      • 4 Replies to jack_hemmer_rides_on
      • the the data handlers stopped the testing on peramivir for FUTILility. yes. you left out the last paragraph on purpose. what else could it have been.

      • Nothing was left out jack, maybe ask first before doling out your labels on people. Thanks Mdaddy for the backup.

        My point was simple to understand and was about FDA (in this case the panel...true) giving a pass to a drug that showed little efficacy but had a great safety profile.

        And if you really wanted to give the rest of the story, you know the part you left out, you would have added the part that a 15/1 vote from an FDA panel is about as good as an FDA approval as it gets...
        ___________________

        And further research shows that GSK back in Nov. 2012 got approval on an MCM anthrax vaccine even after an initial rejection:

        Nov. 6, 2012

        GlaxoSmithKline recently announced that a U.S. Food and Drug Administration committee voted to approve its drug raxibacumab for the treatment of inhalation anthrax, three years after the agency initially denied its approval.

        The FDA’s Anti-Infective Drugs Advisory Committee voted unanimously, 18-0, that raxibacumab fits the required risk-benefit profile, and unanimously with one abstention, 16-1 that the treatment is effective

        ...Issued: 14 December 2012, London UKGlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab

      • From the king of pumpers. Don't throw rocks if you live in a glass house. Map has done amazing research while you comne up with off the wall valuations. Get a grip my man.

      • Yes, we would like the FDA to continue to review Peramivir NDA

    • i'm sure stoney will call upon his "20 years of global experience" to put together a "presentation of a lifetime" to bid for approval.

      now that would be funny...

      • 1 Reply to huskys4u2
      • From Archived EUA materials-1891 patients with acute uncomplicated, hospitalized not evaluated, treatment of pediatric patients approved if criteria apply, for patients unable to take oral medicine or for whom oral not effective, -so, what were results of all these uses, 2000+EUA? in a form available for those who could not take oral medicine.

        Peramivir - A third neuraminidase inhibitor peramivir formulated for intravenous (IV) administration is an investigational product currently being evaluated in clinical trials. As of October, 2009, safety and/or efficacy data from 1,891 patients with acute uncomplicated seasonal influenza A has been submitted to the FDA. Efficacy and safety have not been evaluated in hospitalized patients. Even though the data are insufficient to allow FDA approval, the FDA issued an EUA for treatment with peramivir of hospitalized patients with 2009 H1N1 influenza who have potentially life-threatening suspected or laboratory confirmed infection. Peramivir IV is available through the CDC upon request of a licensed physician. Under the EUA, treatment of adult patients with IV peramivir is approved only if: (1) the patient has not responded to either oral or inhaled antiviral therapy; (2) drug delivery by a route other than IV is not expected to be dependable or is not feasible; or (3) the clinician judges IV therapy is appropriate due to other circumstances. Treatment of pediatric patients is approved if either of the first two criteria apply.

        Patients who have severe, complicated, or progressive illness or who are hospitalized
        Treatment is recommended for patients with confirmed or suspected 2009 H1N1 influenza who have severe, complicated, or progressive illness or who are hospitalized. The recommended duration of treatment is 5 days. Hospitalized patients with severe infections (such as those with prolonged infection or who require intensive care unit admission) might require longer treatment courses. Even though treatment is most effective when started in the first 48 hours of illness, limited data from observational studies of hospitalized patients suggests treatment of persons with prolonged or severe illness reduces mortality or duration of hospitalization even when treatment is started more than 48 hours after onset of illness. Antiviral doses recommended for treatment of 2009 H1N1 influenza in adults or children 1 year of age or older are the same as those recommended for seasonal influenza (Table 1). Some experts have advocated use of doubled doses of oseltamivir for some severely ill patients, although there are no published data demonstrating that higher doses are more effective. For patients unable to take oral medication or in whom oral medication appears to be ineffective, peramivir for intravenous administration is available from the CDC under an FDA EUA, although studies of efficacy and safety are limited. For further information on treatment of hospitalized patients see, “Antiviral Treatment Options, including Intravenous Peramivir, for Treatment of Influenza in Hospitalized Patients for the 2009-2010 Season” and “Updated Recommendations for Health Care Providers of Children and Adolescents on the Use of Antiviral Medications for the Management of 2009 H1N1 and Seasonal Influenza for the 2009-2010 Season”.

 
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