FDA pauses Concert Pharma's hair loss study: 4 things to know

The Food and Drug Administration on Wednesday placed a clinical hold on Concert Pharmaceuticals' trial for a drug to treat the hair loss condition alopecia areata, reports Reuters.

Here are four things to know.

1. The agency stopped the phase two clinical trial before patient dosing began, requesting more data on toxicology studies to support the one-year planned dosing for the trial, reports MarketWatch.

2. Concert said the clinical hold did not stem from any safety concerns involving the drug.

3. The drugmaker plans to submit the requested information to the FDA soon. Once submitted, the agency will have 30 days to review the information and decide whether to lift the clinical hold.

4. Concert is competing with Aclaris Therapeutics, who is developing a similar hair loss drug, to receive the first FDA approval for an alopecia areata treatment, reports Reuters.

More articles on supply chain:

Viewpoint: Why healthcare needs more 'me too' drugs
FDA safety warning: Diabetes drug causes higher risk of foot, leg amputations
Senate health commitee OKs FDA user fee reauthorization bill

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Learning Opportunities

Featured Whitepapers

Featured Webinars