With HPV vaccine uptake slow to take off in the U.S. way back when, Merck & Co.'s Gardasil shots missed out on many eligible patients. But now, Merck has another chance—and so do the men and women who didn't get their shots the first time around.
The FDA on Friday expanded Merck & Co.’s Gardasil 9 approval to men and women ages 27 to 45 from the previous age range of 9 to 26 years. That's a fast nod after a June priority review designation, but it comes about 10 years after Merck first asked.
The new nod is expected to pad growth by revving up U.S. sales at a time when the Gardasil franchise has been leaning on China and Europe for its burgeoning numbers. Human health chief Adam Schechter said in July that management believes the franchise “remains a significant growth opportunity moving forward,” as the 27-to-45 population “will represent another very important opportunity for us in the United States.”
Because Gardasil 9 and sister shot Gardasil are manufactured similarly, the FDA based the Gardasil 9 decision on results from a study of its predecessor. The study followed about 3,200 women aged 27 to 45 for three-and-a-half years and showed that Gardasil was 88% effective in preventing vulvar, vaginal and cervical precancerous lesions, as well as genital warts and cervical cancer related to HPV. A long-term followup showed no additional cases of HPV disease for at least 10 years after vaccination, Merck spokeswoman Pamela Eisele previously told FiercePharma.
Effectiveness of the 9-valent shot in men 27 through 45 years of age is also inferred from the data above, as well as previous Gardasil efficacy data in younger men and immunogenicity data in the new age group, said the FDA.
The HPV immunization rate has been growing in the U.S. According to the CDC’s latest report, about half of adolescents had completed the full course by 2017. But still, that was far short of the 80% goal health officials are aiming for in adolescents aged 13 to 15, as laid out in the HHS’ “Healthy People 2020” plan.
The CDC currently encourages HPV vaccination for boys and girls at age 11 or 12 years, before they become sexually active. If they get it before age 15, only two doses are needed, per the agency’s new recommendation as of 2016, while the others still need three doses.
Gardasil 9 is the only HPV vaccine available in the U.S., as Gardasil is no longer distributed in the country and GlaxoSmithKline’s bivalent rival Cervarix has exited the market. While transitioning to the two-dose regimen for youngsters put some near-term pressure on the vaccine’s U.S. sales, growth has been strong thanks to ex-U.S. expansion. In the second quarter, sales of the Gardasil franchise jumped 26% to $608 million at constant exchange rates, powered by growth in China and Europe.
The FDA expansion now means insurance coverage for the older age group will likely follow. Now, individuals have to pay hundreds of dollars out of pocket for off-label use if they want to make up for their missed HPV vaccination.
Outside of the U.S., China in April approved Gardasil 9 after a mid-2017 approval for Gardasil. Once it was launched, reports soon emerged that supplies were running low as women busted clinics’ appointment lines looking for a shot.
“The uptake in China has been larger than what we would have initially anticipated, and we’re still trying to ensure that we understand what’s the demand there because this is such a large opportunity,” said Schechter on the second-quarter call.
In its World Preview 2018 report in June, pharmaceutical intelligence firm Evaluate Pharma predicted Gardasil franchise’s global sales will grow from $2.38 billion in 2017 to $3.28 billion in 2024.