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Targeted Therapies in Asthma: Update Bulletin # 3 [October 2018]

Product Code:
Publication Date:
October 2018

This edition presents the views and insights from three of the world’s foremost key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the severe asthma market. Within this update, KOLs provided their views on the following key events; Glenmark Pharmaceuticals announcing results from a Phase I study involving GBR 310, a proposed omalizumab biosimilar; the European Commission granting a marketing authorisation for Nucala (mepolizumab; GlaxoSmithKline) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years; GlaxoSmithKline announcing results from an indirect treatment comparison of the licensed doses of Nucala, versus benralizumab (Fasenra; AstraZeneca) and reslizumab (Cinqair/Cinqaero; Teva) in patients with severe eosinophilic asthma; AstraZeneca and Amgen announcing that the FDA had granted breakthrough therapy designation to tezepelumab in patients with severe asthma without an eosinophilic phenotype; and AstraZeneca announcing results from the BORA Phase III extension trial evaluating the long-term safety and efficacy of Fasenra (benralizumab) as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed the Phase III SIROCCO or CALIMA trials.

Business Questions:

• Do KOLs believe omalizumab biosimilars are needed in the management of severe asthma, or are they likely to be chasing a declining market?
• With Roche and Novartis potentially facing omalizumab biosimilar competition, what options do the companies have when it comes to competing with omalizumab biosimilars?
• Have KOLs welcomed Nucala’s paediatric label in Europe, or do they have any concerns?
• Will the wider anti-IL-5 class benefit from Nucala’s paediatric label via ‘halo effect’, or will the impact be limited to Nucala?
• What questions have KOLs raised in terms of GlaxoSmithKline’s claims that mepolizumab is the superior anti-IL-5?
• Following tezepelumab receiving a breakthrough therapy designation in the US, how excited are KOLs about this?
• Do KOLs really believe that tezepelumab has the potential to treat a broad population of severe asthma patients, including those that are ineligible for currently approved biologic therapies?
• What data are KOLs expecting for tezepelumab in terms of efficacy and safety from the Phase III NAVIGATOR and SOURCE studies?
• Subject to approval, how and when will tezepelumab be used in the severe asthma treatment paradigm, and what impact could it have on other severe asthma biologic treatments?• Subject to approval, how and when will tezepelumab be used in the severe asthma treatment paradigm, and what impact could it have on other severe asthma biologic treatments?
What is the key message that comes out of the long-term BORA study in relation to the safety of benralizumab?



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