Good news flowed in at Gilead Sciences (GILD) with the FDA clearing two of its HIV drugs — Tybost (cobicistat) and Vitekta (elvitegravir). Tybost has been approved in combination with other antiretroviral agents for treating patients with HIV-1 infection. Cobicistat acts as a “boosting” agent, whose addition causes blood levels of protease inhibitors, such as Bristol-Myers’ (BMY) Reyataz and Johnson & Johnson’s (JNJ) Prezista to increase, thereby enabling the HIV therapy to be dosed once daily.
Vitekta, which works by interfering with HIV replication, gained FDA approval for use in treatment experienced HIV-1 infected adults in combination with an HIV protease inhibitor co-administered with AbbVie’s (ABBV) Norvir (ritonavir) and other antiretroviral treatments.
Second Time Lucky for these Drugs
The path leading to FDA approval has been anything but smooth for Tybost and Vitekta. Last year, the FDA declined to approve the drugs for use as part of HIV therapy regimens and issued complete response letters (read more: Double Setback for Gilead). Following the receipt of the complete response letters, Gilead resubmitted the new drug applications and the FDA assigned target dates of Oct 3 and Oct 4 for deciding on Tybost and Vitekta respectively. However, the U.S. regulatory body arrived at its decision well before the PDUFA dates.
EU Approval Already in the Bag
The EU approval of these drugs has however been smooth. Tybost was cleared in the EU in Sep 2013. European approval for Vitekta was gained in Nov 2013. The sales potential of the HIV drugs would increase following their clearance in the U.S.
Gilead carries a Zacks Rank #1 (Strong Buy). Medivation (MDVN) is an equally well-ranked stock in the health care space.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment