logo
Plus   Neg
Share
Email

ViiV Healthcare Seeks FDA Approval For Two-drug To Treat HIV-1 Infection

ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK.L,GSK) and Pfizer Inc. (PFE), has submitted a New Drug Application to the US Food and Drug Administration seeking approval for an investigational, monthly, injectable, two-drug regimen of Rilpivirine and Cabotegravir for the treatment of HIV.

In pivotal phase III studies, dubbed ATLAS and FLAIR, the combination of Janssen's Rilpivirine and ViiV's Cabotegravir injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.

ViiV Healthcare and Janssen plan to submit regulatory applications for the two-drug regimen of cabotegravir and rilpivirine to the European Medicines Agency, Health Canada and other global agencies in the coming months.

As part of the regulatory submission package to the FDA, a second NDA was submitted for an oral tablet formulation of Cabotegravir that would be taken once-daily as an oral lead-in with the already-approved oral tablet formulation of Rilpivirine (marketed by Janssen as EDURANT).

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Microsoft Corp. (MSFT) founder Bill Gates has admitted that his greatest mistake was allowing Google's android to become a dominant mobile operating system. Speaking at a Economic Club of Washington luncheon, Gates said to David Rubinstein on Monday, "We're in the field of doing operating systems... McDonald's said Monday that the introduction of fresh beef at its restaurants just over one year ago has helped it gain market share in the informal eating out or IEO category for the first time in five years. In May 2018, the burger chain switched to fresh beef quarter-pound burgers from frozen beef across the U.S., as part of its efforts to provide customers with a "hotter, juicer burger." 'Toy Story 4' has broken global office box records for an animated movie, according to media reports. The movie is the fourth instalment in the 'Toy Story' series and is the sequel to 2010's 'Toy Story 3.' The Disney and Pixar film has reportedly earned $238 million after opening worldwide over the weekend and performed particularly well in Latin America and Europe.
Follow RTT