FDA approves IND for Vectura's VR647
VR647 is a drug/device combination, using the AKITA JET smart nebuliser, for the delivery of nebulised budesonide.
Vectura has received an Investigational New Drug (IND) approval from the FDA to conduct a Phase I 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 8 years) for the US market. This wholly-owned pipeline programme seeks 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 (NDA). This approach requires a small number of clinical studies whose costs are within the Group's existing guidance for R&D 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. According to IMS, US sales of nebulised budesonide are approximately $830 million per year.
The Phase I pharmacokinetic study in adults is expected to be initiated in H1 2017 and will inform the doses to be explored in a Phase II study in children planned for H2 2017. These studies will be conducted to support initiation of a Phase III study in H2 2018 with the NDA filing anticipated in 2020.
James Ward-Lilley, CEO, commented: "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."
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance