VR647 is a drug/device combination, which uses Akita Jet smart nebulizer, to deliver nebulised budesonide for maintenance treatment and prophylactic therapy of asthma in children between 12 months and 8 years.

According to the company, the wholly-owned pipeline programme seeks to significantly improve the currently available nebulised delivery of budesonide with enhanced delivery time and better lung deposition where there is potential for reducing the dosage whilst maintaining similar efficacy.

Vectura is planning to start phase I pharmacokinetic study in the first half of this year, and will explore the doses in a phase 2 study in children in the second half of the year.

The studies are expected to provide support to start Phase III study in the second half of 2018, while the NDA filing is anticipated in 2020.

Vectura Group CEO James Ward-Lilleys said: “VR647 offers substantial potential harnessing of Vectura’s innovative smart nebuliser technology for superior delivery of an existing drug with a proven track record in an established and significant US market.

“The FDA’s approval is an important milestone allowing us to commence an accelerated clinical programme ahead of potential launch in 2021 as a self-commercialised asset.”