CONNECT WITH US
Tech

Tech

The FDA wants to pull its approval of a drug. It’s not so easy.

Ars Technica - Tech logo

Published on

Add as a preferred source on Google
The FDA wants to pull its approval of a drug. It’s not so easy.

In May 2021, the US Food and Drug Administration released a lengthy briefing document on an experimental medication for a rare autoimmune form of vasculitis that often damages the kidneys and lungs. The agency was on the fence about whether to approve the treatment, and it wanted an independent advisory committee to weigh in. Among the questions at hand: Was the drug meaningfully better than existing therapies?

Participants in the study, which had been conducted by the California biotechnology company ChemoCentryx, did appear to have slightly higher rates of symptom remission after one year. But according to the FDA, it was hard to interpret the results because the study’s design had been less than optimal. Some advisory committee members expressed a similar view. The effect of the drug, said one, “is just not well verified by this study.”

At the same time, many patients, and some physicians, saw in the data a potentially helpful medication, one that might lessen patients’ reliance on steroids, which are highly effective but often cause severe side effects.



Source link
Related Topics:Tech

Disclaimer

We strive to uphold the highest ethical standards in all of our reporting and coverage. We TheMorningPulse.fyi want to be transparent with our readers about any potential conflicts of interest that may arise in our work. It's possible that some of the investors we feature may have connections to other businesses, including competitors or companies we write about. However, we want to assure our readers that this will not have any impact on the integrity or impartiality of our reporting. We are committed to delivering accurate, unbiased news and information to our audience, and we will continue to uphold our ethics and principles in all of our work. Thank you for your trust and support.