Vectura gets FDA investigational approval for VR647

Device and formulation business for inhaled airways disease, Vectura Group, announced on Tuesday it has received an ‘Investigational New Drug’ approval from the US Food and Drug Administration for its VR647 product.

The FTSE 250 firm said the approval will allow it to conduct a Phase 1 clinical trial with VR647.

“VR647 is a drug-device combination, using the ‘AKITA JET’ smart nebuliser, for the delivery of nebulised budesonide for maintenance treatment and prophylactic therapy of asthma in children 12 months to eight years, for the US market,” the company’s board said in a statement.

It said the wholly-owned pipeline programme was seeking to “significantly improve” the currently available nebulised delivery of budesonide with a faster delivery time and better lung deposition where there is potential for reducing the dosage whilst maintaining similar efficacy, thereby reducing the risk of local and systemic side effects.

“In June 2015 the FDA agreed with the group's plan to rely on the 505(b)(2) pathway for the development programme with the aim of filing a New Drug Application.

“This approach requires a small number of clinical studies whose costs are within the group's existing guidance for research and development investment.

“In line with its existing strategy to selectively build a specialist sales capability alongside the group's continuing and proven partnering model, VR647 offers a further potentially significant source of recurring revenue.”