New quad HIV pill passed by FDA
pharmafile | September 2, 2012 | News story | Sales and Marketing | FDA, Gilead, HIV, stribild
Gilead’s four-in-one anti-HIV once-daily pill Stribild has been given the green light by the FDA for adults who have not been treated before.
It is the first to contain an an integrase inhibitor (elvitegravir), the class of compounds which block the ability of the HIV virus to integrate into the genetic material of human cells, thus preventing replication.
The FDA’s decision had been expected since Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) was overwhelmingly backed in May by an influential committee of advisors.
Cobicistat is a boosting agent and emtricitabine and tenofovir disoproxil fumarate are already on the market as a 2-in-1 called Truvada.
Deutsche Bank analyst Robyn Karnauskas has predicted that Stribild could generate $4 billion in peak annual sales.
HIV is a highly important therapy area for Gilead: it markets the most-prescribed HIV combination pill Atripla (efavirenz and Truvada) with Bristol-Myers Squibb.
And last year three-in-one daily treatment Complera – expected to generate over $500 million in revenues in 2013 – was approved in the US as a first line treatment for HIV, combining Truvada and Janssen R&D Ireland’s rilpivirine.
In phase III trials Stribild proved non-inferority to Atripla and to a regimen containing ritonavir-boosted atazanavir plus Truvada.
Stribild will cost $28,500 a year – 12% more than Atripla – but analyst GlobalData says this might have been higher and suggests Gilead listened to entreaties on price from the AIDS Healthcare Foundation.
Gilead has also given some Indian manufacturers the right to develop generic versions of Stribild and distribute them to developing countries.
HIV treatment has been steadily moving towards combination pills, which patients find easier to take than having to think about multiple tablets in their self-care regime.
“Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success,” said Gilead chief executive John C. Martin.
Marketing applications for Stribild are pending in Europe, Australia and Canada and the European Union.
Adam Hill
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