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Chronic Obstructive Pulmonary Disease (COPD): Update Bulletin #2 [October 2018]

Product Code:
596201009
Publication Date:
October 2018
Format:
PDF
Price:
$1,095

This edition presents key opinion leader (KOL) views on recent developments in the chronic obstructive pulmonary disease (COPD) market. Topics covered include: the FDA Advisory Committee (AdCom) decision on GSK’s Nucala (mepolizumab) as an add-on to inhaled corticosteroids for the treatment of exacerbations of COPD; AstraZeneca announcing top line results from Phase IIIb trials of Bevespi Aerosphere versus GSK's Anoro Ellipta on peak forced expiratory volume in one second (FEV1); detailed analysis of AstraZeneca’s Phase III KRONOS study with its triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate); Verona Pharma presenting milestone data for its first-in-class, inhaled, dual phosphodiesterase-3/phosphodiesterase-4 (PDE3/4) inhibitor RPL554; and Theravance Biopharma and Mylan presenting new Phase 3 data for Yupelri (revefenacin) on COPD exacerbations.

Business Questions:

• Why did the FDA AdCom reject Nucala as an add-on to ICS treatment, and what trials will GSK need to undertake to gain approval?
• Is there a future for anti-IL5 mAbs in the treatment of COPD?
• How does AstraZeneca Bevespi Aerosphere (glycopyrronium/formoterol fumarate) stack up against Anoro Ellipta (umeclidinium/vilanterol) on COPD exacerbations?
• Why did Astra Zeneca evaluate lung function rather than targeting non-inferiority as the primary endpoint in the AERISTO trial?
• What impact, if any, will the AERISTO trial data have on physician prescribing habits of Bevespi Aerosphere (glycopyrronium/formoterol fumarate?
• How effective is AstraZeneca’s triple combination PT010 (budesonide/glycopyrronium/ formoterol fumarate) compared to the LABA/LAMA Bevespi Aerosphere (glycopyrronium/formoterol fumarate) on COPD exacerbations?
• What differentiating features could AstraZeneca leverage in order to allow PT010 to compete with Chiesi’s Trimbow MDI inhaler?
• How effective is the PDE3/4 inhibitor RPL554 as an add-on with dual LAMA/LABA therapy?
• How do KOLs view the safety profile of nebulised RPL554, and will further trials be required to confirm this assessment?
• Do KOLS think that RPL-554 nebulised formulation will limit its market penetration, or provide new opportunities for combination therapies?
• What clinical trials would KOLs advise Verona Pharma to initiate in order to optimise the commercial development of RPL554?
• What conclusions, if any, can be drawn from the recent Phase III results regarding the effect of Yupelri (revefenacin) versus Spiriva HandiHaler (tiotropium) on COPD exacerbations?
• Can KOLs identify any unique selling features for Yupelri that will enable it to differentiate from other approved LAMAs?





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