Positive Phase III results in high-risk patients expected to support FDA review process for Roche’s Xofluza

18-Jul-2018

Following the recent news that Roche has announced positive top-line results from its Phase III trial for influenza drug, Xofluza, Tom Moore, Senior Healthcare Analyst at GlobalData, a leading data and analytics company, offers his view

Positive Phase III results in high-risk patients expected to support FDA review process for Roche’s Xofluza

“Xofluza is forecast to reach annual sales of $600 million by 2024. Although the drug is on track to be marketed globally, the majority of these sales are expected to come from Japan, where brand loyalty to Shionogi, and a historical preference for branded products compared with generics, is expected to give the drug a boost over competitors."

“Xofluza’s major competitor in the flu market will be Tamiflu, also marketed by Roche. Although Xofluza offers an improved dosing regimen and some benefits in efficacy compared to Tamiflu, competition from recently launched generics is expected to hamper sales in the US and Europe."

“Yesterday’s results support previously published positive efficacy data from a separate Phase III trial enrolling lower risk influenza patients. Xofluza is currently being reviewed for approval by the FDA, and Roche will expect these results to be taken into consideration when deciding how the product will be indicated in the US.”

Xofluza is the first single-dose antiviral for the treatment of influenza, and has a novel mechanism-of-action.

Sign up for your free email newsletter

The drug was developed by Shionogi, which has been marketing it in Japan since it launched in 2017. However, Shionogi have partnered with Roche to market the drug throughout the rest of the world.

Companies

Featured Companies

Related Content

Pistoia Alliance announces data management toolkit
Pistoia Alliance announces data management toolkit
Eli Lilly’s acquisition of Loxo Oncology will result in quick return of investment
Eli Lilly’s acquisition of Loxo Oncology will result in quick return of investment
BMS' acquisition of Celgene could position the company amongst top five most profitable pharma giants
BMS' acquisition of Celgene could position the company amongst top five most profitable pharma giants
Drug pricing and reimbursement concerns will remain the leading impediment to industry growth in 2019
Drug pricing and reimbursement concerns will remain the leading impediment to industry growth in 2019
R&D returns fall to lowest level in 9 years, says Deloitte and GlobalData
R&D returns fall to lowest level in 9 years, says Deloitte and GlobalData
Drug development in neuroimmunology to witness strong growth in the 8MM
Drug development in neuroimmunology to witness strong growth in the 8MM
Immuno-oncology drug development and personalised medicine will continue to reshape the pharma industry in 2019
Immuno-oncology drug development and personalised medicine will continue to reshape the pharma industry in 2019
Big Data and AI to transform healthcare by driving innovation, growing revenues and increasing operational efficiencies
Big Data and AI to transform healthcare by driving innovation, growing revenues and increasing operational efficiencies
GSK and Pfizer deal shows shift in strategy shift to create the leader in over-the-counter products
GSK and Pfizer deal shows shift in strategy shift to create the leader in over-the-counter products
Bayer receives European approval for haemophilia drug Jivi ... but has stiff competition ahead
Bayer receives European approval for haemophilia drug Jivi ... but has stiff competition ahead
Global atopic dermatitis market set to reach $18.3 billion by 2027
Global atopic dermatitis market set to reach $18.3 billion by 2027
Pfizer’s palbociclib is the top breast cancer drug used in clinical trials initiated in 2018
Pfizer’s palbociclib is the top breast cancer drug used in clinical trials initiated in 2018
Pharma companies may miss crucial EU drug packaging deadline with a no-deal Brexit
Pharma companies may miss crucial EU drug packaging deadline with a no-deal Brexit
Commercial prospects for immuno-oncology development across oncology indications in untapped cancer types or in combinations
Commercial prospects for immuno-oncology development across oncology indications in untapped cancer types or in combinations
Non-small cell lung cancer market projected to be worth $14.6 billion by 2024
Non-small cell lung cancer market projected to be worth $14.6 billion by 2024
Significant advances in diabetes medicine have been made, but many unmet needs remain
Significant advances in diabetes medicine have been made, but many unmet needs remain