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EU backs Gileads Eviplera medication

Gilead Sciences, Inc. seem to be having a great year with the later announced a good news about the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for its once-daily single tablet regimen (STR) for the treatment of HIV in previously untreated adults.

The tablet, which will be marketed as Eviplera, is a combination of Gilead’s most popular HIV drug, Truvada (a fixed-dose, once-daily tablet containing Gilead’s Viread and Emtriva), and Johnson and Johnson’s recently approved HIV drug Edurant.

However, the CHMP limited the use of Eviplera only in patients with low viral load that is below 100,000 HIV RNA copies/mL. Thus, they believe that the positive opinion will lead to European approval. Later, the EMA will pass its decision this year.

The drug was approved in August by the US Food and Drug Administration (FDA) this year under the trade name of Complera. Complera/Eviplera is the second STR approved for the treatment of HIV, the first being Atripla, which is marketed by Gilead and Bristol Myers Squibb. ECHO and THRIVE were the two studies conducted later this year for 48-weeks on which the European filing was based.

Gilead’s strategy of creating fixed-dose combinations of existing HIV/AIDS drugs has been a resounding success. Gilead’s most popular HIV combination medicines, Truvada and Atripla (a combination of Truvada and Bristol Myers’ Sustiva), have allowed the company to maintain robust growth in HIV product sales.

Very recently, Gilead announced positive data from two late stage studies of another investigational HIV combination pill, Quad. The much anticipated Quad pill is a combination of Gilead’s pipeline candidate elvitegravir, cobicistat (GS 9350), and Truvada. Gilead hopes to begin regulatory filings in the US by the end of the year. The new drug application (NDA) will include data from both study 102 and 103.

Gilead will request the FDA to grant priority review status to the NDA, which if granted is expected to lead to approval of Quad by mid-2012. So, if they get approval, Quad together with Complera/Eviplera will further fortify the HIV franchise and will help to alleviate the impact of upcoming patent expirations.