BMS wins FDA approval for HIV pill
pharmafile | January 30, 2015 | News story | Sales and Marketing | BMS, Bristol-Myers Squibb, FDA, Gilead, Reyataz, atazanavir, cobicistat), evotaz, tybost
Bristol-Myers Squibb has earned FDA approval for its HIV combination treatment Evotaz.
The US drugs regulator gave BMS the go-ahead for Evotaz, a combined treatment containing Reyataz (atazanavir) and Gilead’s Tybost (cobicistat), which can be used along with other retrovirals to treat adults with HIV-1 infection.
The decision was based on key data from a Phase III trial, in which 85% of patients who took Evotaz had low levels of the HIV virus in their blood after 48 weeks.
“We are pleased to provide physicians and patients with an important new option to treat HIV,” says Murdo Gordon, head of worldwide markets at Bristol-Myers Squibb. “Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure and zero protease inhibitor mutations.”
Research published in the Journal of the American Medical Association in July 2014, and presented at an AIDS Conference in Melbourne, found that the rate of HIV infections diagnosed in the US has fallen by a third over the past decade.
An analysis of data from all 50 states found that the diagnosis rate fell to 16 per 100,000 people in 2011 from 24 per 100,000 in 2002. Overall between 2002 and 2011, 493,372 people were diagnosed with HIV in the US – but there are still around 50,000 people diagnosed with HIV every year and an estimated 1.1 million people living with HIV in the US.
Research suggests that only one in four people with HIV in the US are ‘virally suppressed’ – or have a low amount of the virus in their blood and a lower chance of passing the virus on to others.
This is a key feature in HIV drug approvals, says study investigator Joel Gallant, professor of medicine in the division of infectious diseases at the Johns Hopkins University school of medicine.
“Maintaining sufficient drug concentrations inhibits viral replication and prevents the development of resistance, which are critical considerations in treating patients with HIV,” he adds.
Lilian Anekwe
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