Vectura said yesterday that the FDA approved an Investigational New Device application for its drug-device combination to treat asthma in children 12 months to 8 years old. The UK-based company’s device, VR647, uses the Akita Jet nebulizer for the delivery of nebulized budesonide.
Vectura’s drug-device combination product provides faster delivery time and better lung deposition of budesonide, according to the company, and enables a patient to potentially lower their dosage while maintaining efficacy.
“VR647 offers substantial potential harnessing of Vectura’s innovative smart nebulizer technology for superior delivery of an existing drug with a proven track record in an established and significant US market,” Vectura Group CEO James Ward-Lilleys said in prepared remarks. “The FDA’s approval is an important milestone allowing us to commence an accelerated clinical program ahead of potential launch in 2021 as a self-commercialized asset.”
In June 2015, the FDA approved the company’s plan to follow the 505(b)(2) pathway, with the ultimate goal of filing a New Drug Application. The pathway requires that Vectura conduct a small number of clinical studies, which it can begin doing since the FDA approved its IND.
The company plans to initiate its phase I pharmacokinetic study in adults in the 1st half of 2017. The study aims to establish safe dose levels for a phase II study in children, which the company expects will commence in the 2nd half of 2018. Finally, Vectura said it expects to launch a phase III trial in the 2nd half of 2018 and to file the NDA in 2020.
In November last year, Vectura executive James Ward-Lilley was reportedly looking to buy a specialized lung drug business.
Reuters reported that Ward-Lilley was on the hunt for a company with an established U.S. sales force to grow the company’s portfolio and goals as it develops specialized lung drugs that are wholly owned by Vectura.