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
A new survey by the National Restaurant Association or NRA has painted a grim picture regarding the outlook for the U.S. restaurant industry. According to the NRA's Restaurant Industry Tracking survey for May 2020, most restaurant operators in the U.S. said they do not expect their business to return to normal during the next several months. Tyson Foods, Inc. announced that its 815 workers were found to be coronavirus or Covid-19 positive at the facility-wide testing in two Iowa plants in Council Bluffs and Storm Lake. Meanehile, Storm Lake, Iowa pork facility will resume limited production on Wednesday following a temporary halt for additional deep cleaning and sanitizing. Swedish fashion retailer Hennes & Mauritz AB or H&M has temporarily shuttered 95 of its stores in various regions across the U.S. following violence and looting amid the unrest related to the death of George Floyd. Street protests, some peaceful and some violent, erupted across the nation after Floyd was mercilessly killed by Minnesota police.
Follow RTT