An FDA advisory panel overwhelmingly voted 16-2 to recommend Descovy, the fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF), as pre-exposure prophylaxis (PrEP) to reduce HIV acquisition in men who have sex with men (MSM) and transgender women.
But murmurs echoed throughout the room as the FDA’s Antimicrobial Drugs Advisory Committee split 8-10 on whether to recommend a PrEP indication for F/TAF in cisgender women.
While committee members recognized the precedent they were setting in recommending an HIV prevention drug in certain populations over others, it came down to the lack of efficacy data, as drugmaker Gilead Sciences presented only pharmacokinetic data to support the indication for cisgender women, looking to extrapolate efficacy data from the DISCOVER trial. That study had demonstrated F/TAF’s effectiveness in MSM and transgender women having sex with men.
The slim majority of committee members who voted no also appeared unmoved by Gilead’s claim of logistical challenges in conducting a non-inferiority trial among women. The company argued that a dedicated non-inferiority trial would need 22,000 women and 8-10 years to conduct.
“I feel like Arrowsmith — we’re in a desperate situation, so let’s do something because we can do something,” chair Lindsey Baden, MD, of Brigham and Women’s Hospital in Boston, said. “For us to presume the good data are the ones we should hang our hats on [is] presumptuous [and] I cannot support an indication that says efficacy.”
Consumer representative Roblena Walker, PhD, of EMAGAHA Inc. in Mableton, Georgia, went one step further with her “strong no” vote, adding, “I’m highly appalled that more dedication and passion wasn’t put into the study.”
Among the members who voted yes, few expressed enthusiastic support for the data — with several saying they “almost voted no” or “wanted to abstain.” But several cited the potential public health message of having an HIV prevention product that was not recommended for women.
“I reached back to the FDA’s mission statement — to promote and protect public health by helping safe and effective products reach the market in a timely manner,” said Peter Weina, MD, PhD, of Defense Health Headquarters in Falls Church, Virginia. “[We should] follow the FDA’s mission statement to get to market for broadest population possible and monitor the product for continued safety.”
Sarah Read, MD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Rockville, Maryland, voted yes because she said she felt that women were a population “clearly in need of more prevention choices,” adding that it was “reasonable to extrapolate the data.”
Indeed, Gilead said that they are “dedicated to generating this data,” and will be supporting a number of studies in over 3,400 women and adolescents, as well as pregnant and breastfeeding women.
As for the indication in MSM and transgender women, the committee was mostly united — with certain members expressing skepticism over the low number of transgender women included in the study. They also emphasized the need for post-marketing surveillance, given certain concerns over lipid profiles. But the general consensus was that the DISCOVER trial provided the needed safety and efficacy data for Descovy as PrEP in MSM and transgender women.
The two members who voted no had different reasons for doing so. Lori Dodd, PhD, of the NIAID, voted no because of the lack of data in transgender women, but Walker voted no because of the lack of African-American representation in the DISCOVER trial, calling it “a lost opportunity to provide substantial data reflective of the community that is [most] impacted by HIV.”
If approved, F/TAF would be the second product to win a PrEP indication, the first being the fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (F/TDF, Truvada), also made by Gilead.
The FDA does not have to follow the advice of these advisory committees, but it often does.
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