Thu, Apr 17, 2014, 3:43 AM EDT - U.S. Markets open in 5 hrs 47 mins

Recent

% | $
Quotes you view appear here for quick access.

Forest Laboratories Inc. Message Board

  • frankposting frankposting Feb 21, 2012 1:02 PM Flag

    FDA's Brief on Aclidinium

    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM292620.pdf

    Benefit-risk assessment
    Replicate, statistically significant differences between aclidinium 400 mcg BID and
    placebo were demonstrated for the primary efficacy endpoint of 12-hour post-dose AM
    trough FEV1 after 12 weeks of treatment. Secondary endpoints provided additional
    support, including peak FEV1, serial FEV1 measurements, patterns of rescue medication
    usage, and COPD exacerbation data. Adverse events were generally low in incidence,
    but the overall long-term safety database for aclidinium 400 mcg BID is relatively
    modest compared to other COPD development programs. In this context, a small
    imbalance in cardiovascular deaths was observed for aclidinium 400 mcg, and subsequent
    additional data from long-term exposure suggests a possible dose-dependence. Whether
    these results represent a spurious finding or a potential safety signal is difficult to discern
    and may warrant further investigation. This issue is of particular importance given the
    concern for possible increased mortality that has been raised with other inhalational
    anticholinergic agents.

    Aclidinium's peak potential: $195M

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Why does FDA extend the review? FDA's notes clearly said the following:

      "Adverse events were generally low in incidence, but the overall long-term safety database for aclidinium 400 mcg BID is relatively modest compared to other COPD development programs. In this context, a small imbalance in cardiovascular deaths was observed for aclidinium 400 mcg, and subsequent additional data from long-term exposure suggests a possible dose-dependence. Whether these results represent a spurious finding or a potential safety signal is difficult to discern and may warrant further investigation."

      The panel suggested a post-marketing study. Seems that FDA thought it is not enough or unappropriate -- CV deaths weighing too much!

      Black Boxed Warnning? But the dose-proportionality is just a possibility based on current data. FRX definitely will argue to any Black Boxed Warnning. Then, FDA would ask FRX to clarify that "possibility" ...... We have to wait for at least three more months to know.

    • This is really disappointing. Obviously we need to see the outcome but whomever constructed the development program looks like they were interested in saving some money ( FDA comment it was too small) in lieu of understanding the field. Guess we will see soon enough.

 
FRX
90.29+1.95(+2.21%)Apr 16 4:00 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.
Google Inc.
NasdaqGSWed, Apr 16, 2014 4:00 PM EDT
Google Inc.
NasdaqGSWed, Apr 16, 2014 4:00 PM EDT