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Hikma Pharmaceuticals and Vectura hit by US regulatory setback

Hikma hit a roadblock with the US Food & Drug Administration as it lodged an abbreviated new drug application for asthma treatment Advair Diskus, first developed by GlaxoSmithKline
inhaler
The companies are developing an advance on the traditional inhaler

Two UK drug companies have suffered a setback at the hands of the American regulator.

Generics giant Hikma Pharmaceuticals PLC (LON:HIK) and inhaled medicines specialist Vectura Group PLC (LON:VEC), are jointly developing a cheap version of GlaxoSmithKline plc’s (LON:GSK) top selling asthma treatment, Advair Diskus.

Hikma hit a roadblock with the US Food & Drug Administration as it lodged an abbreviated new drug application for the product, also known as VR315.

Number of questions 

A number of questions were raised by the FDA in what’s called a complete response letter and while the majority were addressed working with the drugs watchdog, one couldn’t be resolved.

The issue was whether Hikma should carry out a clinical endpoint study. The UK company argued it shouldn’t have to, so the matter was taken through the FDA’s dispute resolution process, which upheld the original finding, namely the additional study should be commissioned.

Both Hikma and Vectura said they had prepared for this outcome with patient enrolment expected in the “coming weeks”. New clinical data will be submitted “as early as possible in 2019”.

Approval by 2020

Approval and launch of the product could happen in 2020, according Vectura chief executive James Ward-Lilley, who called the called the FDA ruling “disappointing”.

"Importantly, we are one of the few first movers into this complex area and in this process we have cleared up a significant number of issues which we believe has strengthened our insight and likelihood of success,” he added.

“These learnings support our confidence that we have the capabilities to achieve US regulatory approval for our extensive inhaled generic pipeline, which includes versions of the three current largest US inhaled brands."

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