Cervical cancer vaccine wins regulator approval
Cervical cancer vaccine wins regulator approval
By Christopher Bowe in New York
Published: June 8 2006 22:19 | Last updated: June 8 2006 22:19. Copyright by The Financial Times
Merck’s Gardasil vaccine to prevent cervical cancer in women received US regulatory approval on Thursday, becoming the second sanctioned vaccine to ward off a cancer caused by infection.
Gardasil prevents infection by four strains of the human papillomavirus (HPV), two of which cause about 70 per cent of cervical cancers and two others that cause genital warts. HPV is sexually transmitted, and about 10,000 American women get cervical cancer each year.
The next big milestone for the US drugmaker and its likely blockbuster product comes on June 29-30, when US public health officials meet to discuss vaccination recommendations. The Centers for Disease Control Advisory Committee is expected to detail age and target populations for vaccination with Gardasil. The committee’s recommendations are often critical to decisions by government and insurers over whether to pay for vaccines.
The Food and Drug Administration approved Gardasil for girls and women aged nine to 26. The FDA said a study in older women was continuing; it has also asked Merck to monitor patients and watch for signs of the vaccines’ protection wearing off.
Merck is the first to launch a cervical vaccine, beating GlaxoSmithKline, the UK drugmaker developing a rival vaccine, Cervarix.
Gardasil is also instrumental in Merck’s struggle to stop declining sales and earnings. Lehman Brothers estimates that the vaccine could reach $3bn in peak annual sales.
Food and Drug Administration officials called Gardasil a “triumph of basic science”. Dr Andrew Von Eschenbach, the acting commissioner, said: “This is . . . not just a good story but a great story for millions of women around the world.”
Dr Baruch Blumberg, developer of a vaccine for liver cancer from hepatitis B, said: “There are probably other cancers, including common cancers, that are associated with viruses or other infectious agents.”
By Christopher Bowe in New York
Published: June 8 2006 22:19 | Last updated: June 8 2006 22:19. Copyright by The Financial Times
Merck’s Gardasil vaccine to prevent cervical cancer in women received US regulatory approval on Thursday, becoming the second sanctioned vaccine to ward off a cancer caused by infection.
Gardasil prevents infection by four strains of the human papillomavirus (HPV), two of which cause about 70 per cent of cervical cancers and two others that cause genital warts. HPV is sexually transmitted, and about 10,000 American women get cervical cancer each year.
The next big milestone for the US drugmaker and its likely blockbuster product comes on June 29-30, when US public health officials meet to discuss vaccination recommendations. The Centers for Disease Control Advisory Committee is expected to detail age and target populations for vaccination with Gardasil. The committee’s recommendations are often critical to decisions by government and insurers over whether to pay for vaccines.
The Food and Drug Administration approved Gardasil for girls and women aged nine to 26. The FDA said a study in older women was continuing; it has also asked Merck to monitor patients and watch for signs of the vaccines’ protection wearing off.
Merck is the first to launch a cervical vaccine, beating GlaxoSmithKline, the UK drugmaker developing a rival vaccine, Cervarix.
Gardasil is also instrumental in Merck’s struggle to stop declining sales and earnings. Lehman Brothers estimates that the vaccine could reach $3bn in peak annual sales.
Food and Drug Administration officials called Gardasil a “triumph of basic science”. Dr Andrew Von Eschenbach, the acting commissioner, said: “This is . . . not just a good story but a great story for millions of women around the world.”
Dr Baruch Blumberg, developer of a vaccine for liver cancer from hepatitis B, said: “There are probably other cancers, including common cancers, that are associated with viruses or other infectious agents.”
posted by Carlos T Mock at 8:43 PM
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