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    Home > Active Ingredient News > Drugs Articles > FDA Approves Gardasil 9, a super HPV vaccine from MSD, with a peak sales of $1.9 billion

    FDA Approves Gardasil 9, a super HPV vaccine from MSD, with a peak sales of $1.9 billion

    • Last Update: 2014-12-12
    • Source: Internet
    • Author: User
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    Source: Biovalley, Dec 11, 2014 Merck & Co has received great news recently Gardasil 9, the successor of Gardasil, has been approved by FDA The bad news, however, is that Gardasil 9 will replace Gardasil as the world's best-selling HPV vaccine; Gardasil will be relegated to the second tier, while sales will decline significantly However, since both of them are their own products, MSD will steal the music Recently, FDA approved Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) to prevent some diseases caused by nine types of human papillomavirus (HPV) The vaccine covers nine types of HPV, five more than Gardasil (4-valent HPV vaccine) which has been on the market Gardasil 9 has the potential to prevent about 90% of cervical, vulvar, vaginal and anal cancers Specifically, FDA has approved Gardasil 9 for use in 9-26-year-old women and 9-15-year-old men to prevent cervical, vulvar, vaginal, anal cancer caused by high-risk HPV (16, 18, 31, 33, 45, 52, 58) and condyloma acuminatum caused by low-risk HPV (6, 11) Gardasil 9 has increased immune protection against five additional types of HPVs (31, 33, 45, 52, 58), which cause about 20% of cervical cancer, not previously covered by FDA approved Gardasil A large study of 14000 women (16-26 years old) in the United States showed that Gardasil 9 was as effective as Gardasil in blocking four common HPV types; in addition, the researchers determined that Gardasil 9 was as effective as 97% in preventing cancer caused by five additional HPV types Clinical trials conducted in 9-15-year-old adolescents (1200 males and 2800 females) confirmed the validity of Gardasil 9 The data showed that the antibody response induced by Gardasil 9 in 9-15-year-old adolescents was similar to that induced by Gardasil 9 in 16-26-year-old females The safety of Gardasil 9 was confirmed in about 13000 men and women Based on these data, FDA approved Gardasil 9 for women aged 9-26 and men aged 9-15 Analysts predict that the annual peak sales of Gardasil 9 will reach US $1.9 billion, and most of the potential market share of the vaccine will come from Gardasil By 2018, Gardasil's sales are expected to shrink to $525 million, with the vaccine once reaching $1.83 billion in 2013 The good news earlier this week was also good news for mosadon A study among young women found that HPV vaccination did not lead to an increase in high-risk sexual behavior.
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