FDA approves Gilead's Odefsey, its second TAF-based single tablet regimen
The US Food and Drug Administration has approved Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients, with the news sending developer Gilead Sciences’ (Nasdaq: GILD) up 1.9% to $88.92 in afternoon trading yesterday.
Emtricitabine and tenofovir alafenamide are from Gilead and rilpivirine is from Janssen Sciences Ireland, a Johnson & Johnson (NYSE: JNJ) company. Odefsey is Gilead's second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV. Last fall, the FDA cleared Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older (The Pharma Letter November 6, 2015).
Potential sales of $1.6 billion forecast
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze