27th Nov 2019 08:26
(Alliance News) - Hikma Pharmaceuticals PLC on Wednesday said it has submitted a response to deficiencies in its US application for a generic version of GlaxoSmithKline PLC's Advair Diskus inhaler.
In 2018, the FTSE 100-listed pharmaceuticals firm received a complete response letter from the US Food & Drug Administration for its generic, which treats asthma and chronic obstructive pulmonary disease, meaning its abbreviated new drug application had not been accepted.
Since then, Hikma has completed a clinical endpoint study and provided other information requested by the FDA. Hikma said its new submission addresses the FDA's questions from the complete response letter.
Chief Executive Officer Siggi Olafsson said: "Our team has worked extremely hard with Vectura to complete a large and challenging clinical study, which we believe demonstrates the safety and effectiveness of our product, and I am very pleased to have responded to the FDA. As we continue to develop our pipeline of complex generics, respiratory products are a key strategic focus for Hikma and our generic Advair submission is an important milestone. We are confident in our ability to bring a generic version of Advair to the US market, which would enable us to improve patient access to this important medicine."
The generic was developed under a global agreement between Hikma and Vectura Group PLC.
Hikma shares were down 0.3% in London early Wednesday at 1,930.00 pence. Vectura shares were up 0.2% at 84.00p.
By Anna Farley; [email protected]
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