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Insmed Incorporated Message Board

  • justarook04 justarook04 May 24, 2014 8:07 AM Flag

    Cystic Fibrosis extended study excerpts from San Diego PT2

    Arikace has been granted orphan drug status by the FDA and the EMA for the treatment of P. aeruginosa infections in CF patients, according to its maker, Insmed.

    In the original trial (CLEAR-108), 129 patients were assigned to treatment with amikacin and 137 were assigned to treatment with tobramycin. The mean age of the patients was 21 and the participants were split fairly evenly by sex. The vast majority were white.

    For the ongoing extension trial (CLEAR-110), 80 of the cystic fibrosis patients continued on amikacin and 88 switched from tobramycin to amikacin.

    Eligible patients who completed CLEAR-108 were given liposomal amikacin for inhalation (590 mg) once daily via an investigational nebulizer system. Patients are scheduled to receive up to 12 cycles of treatment, comprising 28 days on-treatment followed by 28 days off-treatment.

    Bilton noted that sputum density reductions were maintained through the 1-year extension without regard to the baseline medication, and that, in general, patients who switched from tobramycin to amikacin had similar results.

    Serious adverse events were experienced by 28.2% of patients, usually due to hospitalization because of pulmonary exacerbations.

    "We are not seeing anything in this report that is unexpected," commented Denis Hadjiliadis, MD, from the University of Pennsylvania Health System in Pennsylvania. "The main benefit that liposomal amikacin has when compared to tobramycin is that the liposomal formula can be administered once a day."

    However, "where amikacin will fit in the treatment of CF is uncertain," he said. "I think it will depend on the cost of the drug and whether the convenience of once-daily treatment will outweigh increased costs. However, all these drugs are expensive, so I don't think that amikacin -- if it is approved by the FDA -- will be that much more expensive than tobramycin."

    Nonetheless, clinicians would like to have a new drug in their CF treatment armamentarium, he said

    Sentiment: Buy

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    • Hadjiliadis -

      "The main benefit that liposomal amikacin has when compared to tobramycin is that the liposomal formula can be administered once a day."

      Lewis last August -

      "We're going to be the first treatment for CF that's once a day. Compliance is a major issue in this space."

      "You might throw in Arikace frankly more frequently because patients are more likely to take it. And if you're getting to the MIC with once-daily dosing then you might rotate in the other antibiotics less frequently."

      "You know this is really a pretty disruptive introduction into the CF treatment market, to have a once a day portable therapy."

      The rate of market penetration of Victoza - an injection for Type 2 diabetics whose blood-sugar levels were not being adequately controlled by their first-line therapies - demonstrates perfectly what Lewis means by "pretty disruptive" -

      Week / Prescription numbers

      1 ......... 49
      2 ......... 411
      3 ......... 1,057
      4 ......... 1,465
      5 ......... 2,164
      6 ......... 2,703
      7 ......... 3,268
      8 ......... 3,599
      9 ......... 3,911
      10 ....... 4,801
      11 ....... 5,330
      12 ....... 6,043
      13 ....... 6,616
      14 ....... 7,505
      15 ....... 8,090
      16 ....... 8,925
      17 ....... 8,551
      18 ....... 9,814
      19 ....... 10,355
      20 ....... 10,719
      21 ....... 11,728
      22 ....... 10,577
      23 ....... 12,163
      24 ....... 13,021
      25 ....... 13,475
      26 ....... 14,501
      27 ....... 14,340
      28 ....... 14,793
      29 ....... 15,282
      30 ....... 16,231
      31 ....... 14,636
      32 ....... 17,000
      33 ....... 16,908

      Assuming by Week 30 patients were collecting a 30-day supply, by Week 33 the convenience of once-daily dosing over twice-daily dosing had already attracted 64,775 patients.

      Thirty months after the launch roughly 160,000 patients were using the once-daily regimen.

      Fwiw the FDA was approving drugs on the basis of data from foreign clinical trials long before it got its new GAIN superpowers.

    • more qualitative job

 
INSM
13.21+0.03(+0.23%)Sep 19 4:15 PMEDT

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