HIV pill Tivicay gains FDA approval
pharmafile | August 14, 2013 | News story | Sales and Marketing | FDA, GSK, Tivicay, ViiV
ViiV and partner GlaxoSmithKline’s new HIV drug Tivicay has been shown the FDA’s green light for distribution in the US.
The drug, also known as dolutegravir, works by inhibiting integrase, one of the enzymes crucial for HIV replication.
It is taken in conjunction with Ziagen (abacavir) and Zeffix (lamivudine) and is the second antiretroviral in its class to gain approval, after Merck’s Isentress (raltegravir).
But Tivicay is viewed as a more desirable alternative because it is taken once a day in a 50mg dose, as opposed to its competitor’s twice-daily, 400mg regimen.
The drug is expected to be available to buy in US pharmacies later this month. In Europe, it is still undergoing evaluation by the EMA, with submission of files supporting its use with Ziagen and Zeffix expected later this year.
Some analysts predict sales of the drug to hit $900 million by 2017, with peak sales of up $5 billion anticipated. This will come as music to GSK’s ears – the British healthcare giant holds a 76.5% share in ViiV, an HIV-oriented joint venture with Pfizer established in 2009.
Tivicay is the collaborative company’s first launch. The drug was first developed in Japan by Shionogi, a company which now holds a small share in ViiV.
Treatment will cost $1,175 (£760) per month, or $14,105 per year – details that have alarmed a number of charities with operations in the developing world.
Médecins Sans Frontières policy director Rohit Malpani, said: “We are deeply concerned that ViiV’s business strategy will result in dolutegravir being priced out of reach in countries excluded from ViiV’s licensing deals.”
ViiV chief executive Dominique Limet argued, however, that the drug’s cost is consistent with similar products in the US and that it will be licensed for generic production with low income markets in mind.
Tivicay is suitable for use among both adults who have and have not undergone previous HIV therapy and is also approved for children aged 12 and older.
Hugh McCafferty
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