LONDON (Alliance News) - GlaxoSmithKline PLC said Tivicay, its HIV treatment drug developed with Viiv Healthcare Limited, has received positive Committee for Medicinal Products for Human Use (CHMP) opinion in Europe.
The CHMP opinion is based on safety and efficacy data for dolutegravir from four pivotal Phase III studies
These involved people living with HIV who were new to treatment and also those with prior experience of treatment, and included comparators representing antiretroviral treatments commonly used today in the battle against HIV.
More than 2,500 people were treated across these studies, and the regulatory submission also included data in children aged 12 years and older.
A CHMP positive opinion is one of the final steps in the regulatory process leading to the marketing authorisation decision of the European Commission, which is expected early in 2014.
The stock was trading at 1,640.50 pence Friday afternoon, up 0.82 pence or 0.1%.
By Anthony Tshibangu; anthonytshibangu@alliancenews.com;
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Glaxosmithkline (GSK)