Janssen gets diabetes CRL

Share this article:

The FDA issued a Complete Response Letter to Janssen, telling the drugmaker it needs more data about the experimental canagliflozin-metformin treatment for diabetes. The Johnson & Johnson subsidiary said in a statement that the FDA wants data indicating that canagliflozin—known by the brand Invokana, approved earlier this year—is as effective in the combined form as it is when used as a standalone treatment.

PMLive notes that the CRL is not much of a setback for Janssen, because doctors can prescribe the two drugs separately if they want to use them in tandem. The site also notes that the combination is not a unique one—Bristol-Myers Squibb and AstraZeneca are already marketing a dapagliflozin-metformin mix abroad under the brand Xigduo.

This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Your use of this website constitutes acceptance of Haymarket Media's Privacy Policy and Terms & Conditions