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Insmed Incorporated Message Board

  • fudfighter3 fudfighter3 Jan 21, 2014 11:13 AM Flag

    Approved use of Arikace in the US and Europe?

    The Company guidance for some time has been that they intend to ask for FDA and EMA labels for Arikace based upon the totality of the data from all of the Arikace studies.

    The following extract from the Q3 report is confirmation -

    [ In addition, during October 2013 Insmed commenced the Scientific Advice Working Party (SAWP) process with the European Medicines Agency (EMA) and expects to have discussions with the EMA regarding ARIKACE for NTM lung disease during the fourth quarter of 2013. ]

    Much now hinges upon the data from the NTM study due this quarter.

    But we do know that -

    1. Amikacin injection is a proven therapy both for pulmonary NTM infection and multi-drug-resistant Tuberculosis

    2. Arikace has proven efficacy at Phase III in delivering amikacin to a pulmonary infection.

    If this data does indeed demonstrate that Arikace can eradicate amikacin-susceptible Mycobacterium avium complex and Mycobacterium abscessus from their strongholds in the pulmonary macrophages - why would anybody expect amikacin-susceptible Mycobacterium Tuberculosis to fare any differently?

    Coupled with proof at Phase III that Arikace delivered its amikacin payload even in the congested lungs of a CF patient - why wouldn't the FDA and the EMA both approve Arikace as a therapy for serious pulmonary infection by amikacin-susceptible pathogens?

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    • You could also argue, since physicians can prescribe an approved therapy off label, the FDA wouldn't need to provide such a broad approval for Arikace once they have approved the therapy for one condition.

      • 5 Replies to x10bagger
      • One observation in particular last year was particularly illuminating -

        "IV amikacin is used to treat this patient population right now. You can't get enough amikacin into the lung through IV to successfully address this disease."

        Given that the aminoglycosides are classed as Critically Important Antimicrobials - assuming the NTM data is OK, a good way to reduce the opportunity for aminoglycoside-resistant strains of bacteria to evolve would be to approve Arikace for the treatment of all amikacin-susceptible pulmonary infections for which physicians are currently prescribing amikacin injection.

        And given that Tobi is also an aminoglycoside, I'm sure the medical community would much prefer CF patients to use once-daily Arikace rather than the eight capsules a day TIP - a regimen which is unlikely to be rigorously adhered to by many patients if the development of tobramycin resistance within the CF patient population is anything to go by.

        Today's tobramycin resistance is tomorrow's aminoglycoside resistance.

      • 2 things wrong. Insmed launch will be limited to overseas and they will need to trial for a label expansion.Novartis will own most of the world by the time 2016 rolls around( when Arikace will see some limited use )

      • 140 characters, re your prediction -

        "Novartis will own most of the world by the time 2016 rolls around".

        - I'm sure you must be aware of this warning on the TIP packaging -

        [ Coughing up blood (very common) ]

        "Very common" is defined as affecting more than one patient in ten. But at face value that could mean nine out of every ten patients who (for the moment) use that Novartis drug cough up blood.

        Would you mind telling us what proportion of patients inhaling TIP reported coughing up blood?

        And was the recorded incidence based upon studies where the subjects skipped doses as often as they do in everyday life?

        If so - do you think a far higher proportion would be coughing up blood if every patient took all eight capsules a day?

      • 2 things wrong. Insmed launch will be limited to overseas and they will need to trial for a label expansion.Novartis will own most of the world by the time 2016 rolls around( when Arikace will see some limited use )

      • True. But I'd expect the FDA and EMA to be looking at this more from the viewpoint of combating the threat posed by strains of bacteria which have evolved with resistance to commonly-used antibiotics.

        Aminoglycosides are classed by the WHO as Critically Important Antimicrobials. It would be madness for the FDA and EMA to do anything which would encourage physicians to continue to prescribe amikacin injection as a therapy for pulmonary infections.

 
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