Manufacturing issues block Gilead approvals
pharmafile | May 1, 2013 | News story | Manufacturing and Production |Â Â FDA, GileadÂ
The FDA has blocked approval of two of Gilead Sciences’ HIV drugs because of deficiencies in their marketing applications related to manufacturing.
The regulator issued two complete response letters for elvitegravir and cobicistat indicating that it is unable to approve the marketing applications due to “deficiencies in documentation and validation of certain quality testing procedures and methods”, which were observed during recent inspections.
Gilead filed for approval of the two drugs in the US last year, and marketing submissions are also under review in Europe. They are already on the market in four-component HIV therapy Stribilid/Quad – which also includes Gilead’s emtricitabine and tenofovir disoproxil fumarate compounds and was approved by the FDA last August.
Gilead has stressed availability of the combination product will not be affected by the latest regulatory action, and played down concerns that manufacturing issues might also delay approval of sofosbuvir, a candidate drug for hepatitis C which has been tipped as a multibillion-dollar blockbuster.
Elvitegravir is an HIV integrase inhibitor licensed from Japan Tobacco, in the same class as Merck & Co’s Isentress (raltegravir) which had sales of $1.5 billion last year – and the current application is for its use alongside other already-marketed antiretroviral drugs.
Cobicistat – an inhibitor of cytochrome P450 3A (CYP3A) is designed to boost the activity of other drugs and has no direct antiviral activity of its own.
Of the two, elvitegravir is expected to the biggest earner for Gilead, with sales upwards of $500 million-plus at peak. Meanwhile, cobicistat is expected to be a fairly small product for Gilead, with most of its use as a boosting agent coming from combination products that will be launched down the line by Gilead’s partners.
These include Bristol-Myers Squibb – which is looking at the drug alongside Reyataz (atazanavir sulfate) – and Janssen Therapeutics’ with Prezista (darunavir). Analysts have suggested that cobicistat could bring in annual revenues of $250 million or more within three years of launch.
Gilead said it is working with the FDA to address the questions raised in the complete response letter and move the applications forward.
Phil Taylor
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