Hikma has submitted to the US Food and Drug Administration (FDA) its response to deficiencies in its abbreviated new drug application (ANDA) for a generic version of GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol inhalation powder).
Following receipt of a complete response letter (CRL) from the FDA, Hikma said it started a clinical endpoint study in 2018. This study has been completed and it, along with other information requested by the FDA, has been submitted to the FDA for review. The submission addresses the outstanding questions raised by the FDA in its CRL, Hikma said Wednesday.
Siggi Olafsson, Chief Executive Officer of Hikma, 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.”
Hikma’s partner, Vectura Group, in the development of an AB rated substitutable US generic version of Advair Diskus, also issued a statement.
Will Downie, Chief Executive Officer of Vectura, said: “Hikma’s submission is an important milestone in our generic Advair programme. We believe the submission addresses the outstanding questions raised by the FDA in its CRL and remain confident in the prospects for the approval of VR315US. We continue to see a large market opportunity for VR315US and look forward to working with Hikma to bring this product to the market as quickly as possible.”