Regulatory Affairs

FDA turns down generic version of GSK's asthma/COPD inhaler Advair Diskus

PBR Staff Writer Published 12 May 2017

Vectura and its partner Hikma Pharmaceuticals announced that the US Food and Drug Administration (FDA) turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.

Hikma has secured a complete response letter (CRL) from the FDA on the abbreviated new drug application (ANDA).

According to Vectura, the FDA has categorised the CRL as major, and no material issues were raised regarding the substitutability of the proposed device based on the initial assessment.

After completing the review and discussions with the FDA, the companies will provide an update on its application of the generic asthma treatment.

Vectura also said that VR315 programme is expected to receive approval in this year based on the nature of the feedback Vectura.

In addition, the companies are not expecting to receive an approval milestone or sales royalties for VR315 in this year.

West-Ward's fluticasone propionate and salmeterol inhalation powder has been developed for the treatment of asthma. It will also be used as the maintenance treatment for airflow obstruction and to reduce exacerbations in patients with chronic obstructive pulmonary disease.

The asthma treatment will be delivered by using Vectura's 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 50/50 is a twice-daily prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD).

Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.