Nicox gets first US FDA approval

French biotech firm Nicox (Euronext Paris: COX) saw its shares rise 18% to 12.55 euros by late-afternoon trading today, after the company announced it has received its first drug approval from the US Food and Drug Administration.

The FDA has approved the New Drug Application for Zerviate (cetirizine ophthalmic solution 0.24%; formerly AC-170) the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis. The drug’s approval was previously delayed by agency, which on resubmission of the NDA in March this year gave a Prescription Drug User Fee Act (PDUFA) date of September 8, 2017, for its decision.

"Receiving approval from the US FDA for Zerviate is a huge milestone for Nicox and partnering discussions are underway for US commercialization rights," commented Michele Garufi, chairman and chief executive of the ophthalmic drug specialist, adding: "We expect to further solidify our position as a leading ophthalmic R&D company with the anticipated FDA decision on Vyzulta [latanoprostene bunod], which is licensed worldwide to Bausch + Lomb, and the expected commencement of Phase II clinical trials for both NCX 4251 and NCX 47 0. This is an exciting time for Nicox, and we look forward to keeping you updated on our progress."