Date: 2014-04-11
Type of information:
phase:
Announcement:
Company: Vectura (UK)
Product: Favolir
Action mechanism:
Disease: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On April 11, 2014, Vectura has announced that it will initiate a pivotal study in Europe later this calendar year for FAVOLIR, its investigational product for severe, uncontrolled asthma. This decision underlines the Company’s planned strategy for a broad European development programme for FAVOLIR, rather than a country-specific approach, and this decision follows a recent meeting with the German regulator (BfArM) regarding the local development options for the product. Dr. Chris Blackwell, Chief Executive of Vectura: “The feedback that we received from BfArM is in-line with our own expectations. The constructive dialogue that we have had with the BfArM has helped us in our planning for the upcoming European pivotal trial and we look forward to taking the development of FAVOLIR to the next stage.”
-