Merck gets a shot in the arm with expanded label for Gardasil
- The Food and Drug Administration has provided a boost to both Merck & Co and to adults looking to prevent human papillomavirus (HPV) infection, extending approval of the Gardasil 9 vaccine to cover people between the ages of 27 and 45 years.
- Gardasil-9 covers nine different subtypes of HPV and is currently available for use in in the U.S. in males and females aged between nine and 26 years.
- According to the Centers for Disease Control and Prevention, every year about 14 million Americans become infected with HPV. Each year, around 12,000 women are diagnosed with cervical cancer caused by certain HPV viruses, and about 4,000 women die from these cancers. HPV also causes a number of other cancers in men and women.
Merck is one of the top four vaccine companies. Between them, GlaxoSmithKline, Merck, Sanofi and Pfizer have captured most of the R&D and commercial space.
For Merck, Gardasil 9 is its third best-selling medicine, with revenue now pacing to exceed $2 billion annually. A launch in China this past spring should boost sales moving forward as well.
Approval last week of an expanded label for Gardasil should also provide a lift.
"That indication will represent another very important opportunity for us in the United States," said Adam Schechter, president of global human health at Merck, on a second quarter earnings call.
While earlier vaccination targets the ages where exposure to HPV is most likely, a study of the original version of Gardasil in women aged between 27 and 45 showed the vaccine to be 88% effective in the prevention of a slate of infections, precancerous lesions and cervical cancer related to covered HPV types.
The extended approval of Gardasil-9, granted priority review, is based on this data as well as long-term follow-up.
"The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing," said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
Gardasil was initially approved in 2006 for girls and women aged nine to 26 years for protection against cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.
Since then the FDA has approved Gardasil 9, a nine-valent Gardasil-based vaccine, to protect against the original four and an additional five strains of HPV, in both males and females aged nine to 26.
Gardasil 9's uptake, according to a study in 2016, has potential to lower the incidence of cervical cancer and generate substantial savings for the healthcare system over the next three decades.
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