FDA Requests Additional Info on Hikma’s Generic of GSK Respiratory Drug

By Akia Thorpe -

March 14, 2018

Hikma Pharmaceuticals reports that it is has received a response from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application for its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder).Advair/Seretide is a top-selling drug for GSK with 2017 sales of £3.13 billion ($4.37 billion).

In May 2017, Hikma announced it had received a complete response letter (CRL) from the FDA. In the following months, Hikma said it worked collaboratively with the FDA and was able to address and clarify the majority of the questions raised, but there remained an outstanding issue regarding the clinical endpoint study and, in response, the company decided to engage in the FDA’s dispute-resolution process.

Hikma has said that the FDA has now concluded this process and has upheld its original determination and has requested the completion of an additional clinical endpoint study. In anticipation of this as one of the potential outcomes, Hikma said it has finalized the planning of a new clinical study and expects to start patient enrollment in the coming weeks. Hikma said it anticipates being able to submit a response to the FDA with new clinical data as early as possible in 2019. 

Hikma’s fluticasone propionate and salmeterol inhalation powder is indicated for treating asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease and is delivered using proprietary dry-powder inhaler and formulation technology by Vectura, a UK-based drug-delivery company.    

Source: Hikma