The FDA has categorised the CRL as ‘Major’. Hikma is in the process of reviewing the response and will provide an update on its application as soon as practicable once it has completed its review of the CRL and discussed this with the FDA. Based on the initial assessment, no material issues were raised regarding the substitutability of the proposed device.

Given the nature of the feedback, Hikma believes there is a low likelihood of approval this year. Hikma is committed to bringing this important product to the US market and will work collaboratively with the FDA to address their outstanding questions.

Hikma’s fluticasone propionate and salmeterol inhalation powder is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease and is delivered using Vectura’s proprietary dry powder inhaler and formulation technology.