Targeted Therapies In Asthma: Update Bulletin # 3 [April 2019]

This edition presents the views and insights from three of the world's foremost key opinion leaders (KOLs) from the US and EU on a variety of recent events in the severe asthma market, including: the EMA's CHMP recommendation that the monoclonal antibody Dupixent (dupilumab; Regeneron/Sanofi) be approved as add-on maintenance treatment for severe asthma; Novartis receiving European Commission approval for the self-administration of Xolair (omalizumab; Roche/Novartis) as a prefilled syringe formulation; the publication of data elucidating the mechanism of action of Novartis' investigational oral prostaglandin D2 receptor antagonist fevipiprant.

Business Questions:

• How do KOLs react to the CHMP recommendation that Dupixent be approved in the EU as add-on maintenance treatment for severe asthma?
• How do KOLs view the data from the LIBERTY ASTHMA programme which supported the US approval and recommendation for EU approval of Dupixent?
• How safe and well tolerated is Dupixent for patients with severe asthma?
• In which patients and settings will Dupixent be used in the EU and how widely is it already used in the US?
• How do KOLs view the EU approval of the prefilled syringe formulation of Xolair for self-administration?
• Do KOLs have any concerns regarding the self-administration of Xolair?
• Will the availability of the prefilled syringe formulation of Xolair for self-administration give it a competitive advantage over other biological therapies?
• How do KOLs view the publication of new data elucidating the mechanism of action of Novartis' investigational oral prostaglandin D2 receptor antagonist fevipiprant?
• What is the overall outlook for fevipiprant as a potential treatment for asthma?