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Archive: January 2018

The FDA NEEDS to Hear from You!!

Posted on January 23, 2018   |   
Author: Gretchen   |   
0 Comments   |   
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The voice of the patient has a role in the drug development AND approval process. In fact, recent legislation mandates an increased emphasis on incorporating the patient perspective into the regulatory process.

Currently, there are no treatments that the FDA has approved specifically for bronchiectasis. On January 11th, 2018 the FDA convened a meeting of the Antimicrobial Drugs Advisory Committee to review the potential new treatment, Linhaliq, made by Aradigm, and make a recommendation to the FDA on whether or not to approve it for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with Pseudomonas aeruginosa lung infections. Linhaliq is an inhaled version of ciprofloxacin that has undergone several clinical trials to evaluate if it extends the time to the first exacerbation compared to a placebo treatment.

This was the second recent Advisory Committee meeting for a potential bronchiectasis therapy coming after a November meeting where the Committee reviewed and did not recommend another version of ciprofloxacin made by Bayer. The discussion and vote at the Linhaliq meeting were based on a specific and narrowly defined question about whether Aradigm had met the standards of safety and efficacy for the drug’s intended outcome, which was time to first exacerbation. Like the Bayer meeting, the committee voted that Aradigm had not met those standards, however the Advisory Committee only provides recommendations for the FDA to consider. The FDA then makes the final decision. However, an approval after a negative committee vote is very rare.

In this case, the process and the discussions that occurred at the meetings do not adequately reflect the needs, priorities and preferences of the patient community. We are asking you to take the time to read the below background information and use the bullet point template as a guide to share your perspective with the FDA as they enter this critical period of determining whether to approve the applications for inhaled ciprofloxacin.

What were the core issues at the Antimicrobial Advisory Committee Meeting?

  • The primary outcome that the FDA and the pharmaceutical companies used was time to first exacerbation which measured whether there was more time until the patient taking the treatment had an exacerbation as compared to those taking the placebo.
  • Time to first exacerbation is not felt to be the most appropriate outcome to use for the bronchiectasis population as it may not adequately reflect whether patients truly do better and feel better on the new treatment. The Advisory Committee even acknowledged this during their discussion.
  • The Committee, the FDA, the pharmaceutical companies, clinicians and patients have acknowledged that frequency of exacerbations is the better outcome measure.
  • The companies also collected data on whether the treatment lowered the frequency of exacerbations, however the Advisory Committee was not allowed to consider this data when deciding whether to recommend approval of the treatment because of the design of the trial and related regulatory review.

 

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Tags: Bronchiectasis Drugs Bronchiectasis Treatment FDA Linhaliq
Categories: Research

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