Regulatory Affairs

FDA upholds decision on generic version of GSK’s asthma/COPD inhaler Advair Diskus

PBR Staff Writer Published 13 March 2018

The US Food and Drug Administration (FDA) has upheld the earlier decision of turning down Hikma and Vectura’s generic version of GlaxoSmithKline's (GSK) Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

In May 2017, the FDA turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.

During that time, the companies received a complete response letter from the FDA.

Hikma announced that it now received a response from the FDA regarding its abbreviated new drug application (ANDA) for its generic version of Advair Diskus.

Hikma worked with the FDA to solve and address, as well as clarify the majority of the questions raised.

The company decided to engage in the FDA's dispute resolution process due to an outstanding issue with the clinical endpoint study.

The FDA has now concluded the process, which resulted in upholding of original determination and calling for the completion of an additional clinical endpoint study.

Hikma has already completed the arrangements for a new clinical study, which is expected to begin in the coming weeks.

The company plans to reveal the results from the trial in 2019, and will submit a response to the FDA.

Hikma said its 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.

The inhalation powder will be delivered by using ectura's proprietary dry powder inhaler and formulation technology.          

Advair Diskus is a prescription medicine used to treat asthma in patients four years and older, while Advair Diskus 250/50 is a twice-daily prescription medicine used long term to treat COPD.

Advair Diskus 100/50 is claimed to be approved strength for patients aged between four and eleven.

Advair si said to treat two of the main causes of asthma symptoms such as airway constriction and airway inflammation.