New Quad HIV pill on track for FDA approval
pharmafile | May 14, 2012 | News story | Research and Development, Sales and Marketing | BMS, Compera, FDA, Gilead, HIV, The Quad
Gilead Sciences’ four-in-one HIV pill has been given the thumbs up by an FDA advisory group.
The US regulator is set to make a final decision on the Quad – a combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate – by the end of August.
The FDA’s Antiviral Drugs Advisory Committee voted 13 to 1 to approve it for the treatment of HIV-1 infection in treatment-naïve adults.
“With new [US] government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy,” said Andrew Cheng, Gilead’s senior vice president, HIV therapeutics and development operations.
“The Quad is the latest example of Gilead’s ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV,” Cheng added.
Robyn Karnauskas, an analyst with Deutsche Bank in New York, says the Quad could generate $4 billion in peak annual sales.
The safety and efficacy of The Quad, as well as its elements elvitegravir and cobicistat, have not yet been established but new HIV drugs are important to Gilead, which faces patent expiry on other such treatments from 2018.
Last August, three-in-one pill Complera – expected to generate over $500 million in revenues in 2013 – was approved in the US as a first line treatment for HIV.
It combines three antiretroviral drugs – Gilead’s emtricitabine and tenofovir disoproxil fumarate, and J&J’s Edurant (rilpivirine) – in a once-daily pill.
The first complete antiretroviral treatment regimen for HIV-1 for treatment-naïve patients in a single once-daily pill – Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) – is marketed by Gilead and Bristol-Myers Squibb, and made the companies $2.6 billion in sales in 2010.
Gilead’s emtricitabine and tenofovir disoproxil fumarate are already on the market as a 2-in-1 called Truvada.
These combinations have been used as benchmarks: in Phase III trials the Quad proved non-inferority to Atripla and to a regimen containing ritonavir-boosted atazanavir plus Truvada.
The Antiviral Drugs Advisory Committee said patients taking it should be closely monitored for potential kidney problems.
Marketing applications are also pending in Australia, Canada and the European Union.
Adam Hill
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