Dive Brief:
- Nicox’s new drug application for AC-170, its eye drop for treating itchiness associated with allergic conjunctivitis, hit a setback after the Food and Drug Administration said it has issues with a contracted facility which supplies the manufacturer of the finished drug, the company revealed Monday.
- The FDA’s complete response letter was tied to a good manufacturing practice inspection of a third-party facility producing the activate pharmaceutical ingredient cetirizine, an antihistamine.
- Nicox said it had contacted its suppliers to address the issue and plans to resubmit an application for AC-170 once those problems are resolved.
Dive Insight:
The FDA’s letter is a blow to Nicox’s plans for what it presumably hoped was a speedy regulatory approval of AC-170. But Nicox emphasized the FDA's initial rejection was tied solely to the inspection of the third-part API supplier, noting that the regulator had not requested any additional clinical testing or flagged any concerns with the manufacturer of the finished product.
Since receipt of the FDA’s letter, the company said it has been contacting its suppliers to evaluate the timeline for the API manufacturer to address the FDA’s concerns.
A delay for approval of AC-170 could save Nicox a bit of money in the short-term, though. If the drug is approved before December 1, Nicox owes a milestone payment of $35 million in equity to former shareholders of Aciex Therapeutics, which originally developed the drug before being bought by Nicox. If approval comes after December 1, Nicox only owes $10 million in equity.
AC-170 is a formulation of cetirizine, a long approved active ingredient in Johnson & Johnson’s histamine Zyrtec for the treatment of eye itching and swelling associated with allergic conjunctivitis.