ViiV Healthcare, Glaxo’s specialist HIV drugs division, received what is known as a complete response letter from the FDA regarding its application for the cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.
On the plus side, there were no safety issues flagged by the FDA with the once-a-month injection and there is no change to the safety profile of the products used in clinical trials to date.
The FDA is, however, concerned about chemistry manufacturing and controls.
ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this new drug application.
Shares in Glaxo were down 0.8% at 1,798p in early deals.
Huge surprise: @US_FDA rejects approving long-acting cabotegravir/rilpivirine. Chemistry manufacturing an control issues motivate the decision. That means that marketing of this product will be, at least, delayed. https://t.co/mSndcd2ooX— Juan A. Pineda (@japineda_) December 21, 2019