FDA accepts Hikma’s filing for generic of GSK’s Advair

Hikma’s filing for a generic version of GlaxoSmithKline’s Advair Diskus has been accepted by the FDA.

The abbreviated new drug application (ANDA) for the fluticasone propionate and salmeterol inhalation powder – named VR 315 – will see Vectura receive $10 million for its part in the drug’s development.

VR 315 is indicated for the treatment of both asthma and chronic obstructive pulmonary disease (COPD) and is delivered through Vectura’s patented dry powder formulation technology.

Hikma has been provided with a generic drug user free act (GDUFA) goal date of 10 May, 2017. If the drug is eventually accepted by the FDA, Vectura will receive a further $11 million.

Vectura CEO James Ward-Lilley commented: “The FDA acceptance of the ANDA filing is an important regulatory step for our VR315 programme.” He further added that the company’s ‘strong data package’ will lead to the drug’s final approval by the FDA.

The story of VR 315 has been a long time in the making with Vectura originally reacquiring the rights to the compound from Novartis’ Sandoz in 2010. Since then, news of any further developments concerning the drug have been none-existent.

The news will be welcomed by Hikma, whose generics division experienced a dismal 2015. It recently purchased US generics company Roxane in an attempt to recover from its disappointing performance in 2015 – a year that saw a 30% decrease in generics revenue compared to 2014.

GlaxoSmithKline will be less pleased by the news – Advair remains one of its biggest selling drugs, and its next-generation respiratory drugs have not had an auspicious launch in the US.

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