PHARMACY

Study: Gardasil protects women from HPV for more than 8 years

BY Alaric DeArment

MALMO, Sweden A vaccine for human papillomavirus protected women from the HPV 16 strain for an average of more than eight years after they received it, according to clinical study data.

A 290-patient phase 2 study of Merck’s HPV vaccine Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, 18] vaccine, recombinant) was effective for eight and a half years after administration in women who had not received Gardasil’s HPV 16 component.

In another study, of girls and women aged 16 to 26 naive to 14 common types of HPV, Gardasil reduced the number of abnormal Pap test results by 17% to 45%, also reducing colposcopies by 20%, cervical biopsies by 22% and invasive treatments such as surgery by 42%.

“We are encouraged by the extended efficacy data for the HPV 16 component of Gardasil,” University of Washington public health professor and lead study author Laura Koutsky said. “Studies to examine the long-term efficacy of Gardasil are underway.”

HPV types 16 and 18 cause about 70% of cervical cancer cases, while types 6 and 11 cause about 90% of genital warts and about 10% of low-grade cervical changes, lesions and dysplasias.

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OSI Pharmaceuticals EVP to present portfolio at diabetes and obesity conference

BY Allison Cerra

MELVILLE, N.Y. OSI Pharmaceuticals, Inc. announced Thursday that Anker Lundemose, M.D., EVP of OSI Pharmaceuticals will present at the Canaccord Adams Conference in New York, N.Y. on Tuesday, May 12, 2009 at 8:40 a.m. (Eastern Time).

Lundemose will provide an overview on the company’s diabetes/obesity product portfolio and business developments.

The presentation will be webcast live and may be accessed by visiting OSI’s Web site at www.osip.com. A replay of the Webcast will also be available on the Company’s Web site until May 26, 2009.

OSI Pharmaceuticals discover, develop and commercialize high-quality, novel and differentiated personalized medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.

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FDA grants priority review to Prevnar 13

BY Alaric DeArment

COLLEGEVILLE, Pa. The Food and Drug Administration has granted priority review to Wyeth Pharmaceuticals’ application for the pneumococcal vaccine Prevnar 13 (diphtheria CRM[197] protein).

The company submitted the application for the vaccine, a 13-valent conjugate vaccine, on March 31.

Wyeth said it is seeking approval for Prevnar 13 for the prevention of invasive pneumococcal disease and otitis media caused by the 13 serotypes in the vaccine in children ages 2 months to 5 years. Prevnar 13 includes six serotypes in addition to the seven in the earlier version of Prevnar.

“Since its launch in 2000, our seven-valent pneumococcal vaccine, Prevnar, has significantly reduced the incidence of pneumococcal disease among infants and young children in the United States,” Wyeth Pharmaceuticals EVP vaccine research and development Emilio Emini said. “Recently, however, disease due to pneumococcal serotypes not found in Prevnar, particularly serotype 19A, have increased in prevalence in many regions of the world and are a significant public health concern.”

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