28th Jul 2015 07:17
LONDON (Alliance News) - Vectura Group PLC Tuesday said it has held a meeting with thee US Food and Drug Administration about the company's VR647 product and said the talks have "provided a clear direction" for its development.
The VR647 is a budesonide inhalation suspension co-packaged with a Smart Card for use in the breath-actuated AKITA JET nebuliser which is wholly owned by the company, and is used in the treatment of asthma in children.
Vectura is currently trying to improve the nebulised delivery of budesonide using the product.
The company said the FDA has agreed with the company's development programme for VR647 with the aim of filing a new drug application in the second half of 2019.
"The development plan requires a small number of clinical studies that are within our previously guided research and development spend and offers a significant product development opportunity for the company," said Vectura.
"We are pleased with the outcome of the meeting with the FDA. The FDA's feedback has provided clear direction for the remaining studies required for the new drug application and we believe we are well positioned to successfully transition this programme into development," added Interim Chief Executive Trevor Phillips.
Vectura shares were up 0.4% to 176.83 pence per share on Tuesday morning.
By Joshua Warner; [email protected]; @JoshAlliance
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