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Glaxo's ViiV Healthcare Seeks European Approval For Cabotegravir

(Alliance News) - GlaxoSmithKline PLC on Monday said ViiV Healthcare has submitted marketing ...

Alliance News 29 July, 2019 | 8:46AM
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(Alliance News) - GlaxoSmithKline PLC on Monday said ViiV Healthcare has submitted marketing authorisation application to the European Medicines Agency for HIV treatment Cabotegravir.

ViiV Healthcare is majority owned by Glaxo, with Pfizer Inc and Shionogi Ltd as shareholders.

The HIV treatment provider has sought European marketing approval for the investigational, once-monthly cabotegravir treatment, which will be used in combination with Janssen Pharmaceutica's once-monthly, injectable rilpivirine to treat HIV-1 infection in adults who are not resistant to cabotegravir or rilpivirine.

The marketing authorisation application is based on the Antiretroviral Therapy as Long-Acting Suppression and First Long-Acting Injectable Regimen phase III studies that included more than 1,100 patients from 16 countries.

The studies demonstrated the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a daily, oral, 3-drug regimen in maintaining viral suppression throughout the 48-week study period.

"ViiV Healthcare and Janssen also plan to submit additional regulatory applications for cabotegravir and rilpivirine to other regulatory agencies in the coming months, said ViiV Healthcare's Medical Research & Strategy head Kimberly Smith.

Belgium headquartered Janssen Pharmaceutica is owned by US-based medical devices, pharmaceutical and consumer goods company Johnson & Johnson.

Shares in Glaxo were up 0.9% at 1,701.40 pence each in London on Monday morning.

By Tapan Panchal; tapanpanchal@alliancenews.com

Copyright 2019 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
GlaxoSmithKline PLC 1,671.60 GBX 0.83

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