Nicox resubmits AC-170 NDA after API supplier resolves GMP issues

By Gareth Macdonald

- Last updated on GMT


Related tags New drug application Pharmacology Food and drug administration

Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.

The French drug firm announced the resubmission today, explaining that it is seeking approval for AC-170 – which has the provisional brand name Zerviate cetirizine ophthalmic solution - as a treatment for ocular itching associated with allergic conjunctivitis.

The US Food and Drug Administration (FDA) rejected Nicox’s original NDA in a complete response letter (CRL) issued in October​.

At the time Nicox said: “The FDA’s stated reason for the CRL pertains solely to a Good Manufacturing Practice (GMP) inspection at a third party facility producing the active pharmaceutical ingredient (API) cetirizine and supplying it to the manufacturer of the finished product. 

The unnamed API firm has address the problems and been issued with an establishment inspection report (EIR) closing out the inspection according to Nicox.

CEO Michele Garufi said: "Resolution of the FDA's concerns surrounding the API manufacturing site is excellent news for Nicox, allowing us to resubmit the NDA for a potential approval before the end of 2017.” ​He said the firm expects a decision before the end of the year.

US partner

Garufi also outlined Nicox’s commercialization plan if the drug is approved, explaining that the firm has already attracted interest from several parties interested in becoming its partner in the US.

The strategy mirrors Nicox’s plan for its candidate glaucoma treatment latanoprostene bunod - which has the provisional brand name Vyzulta – ​which the firm plans to sell in the US in partnership with Valeant-owned Bausch+Lomb.

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