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XHTML: You can use these tags:The Advisory Committee on Immunization Practices (ACIP)favored the expanded use by a vote of 14-0 with one abstention, the CDC said.
Prevnar 13, one of Pfizer's most important products, prevents pneumococcal pneumonia or invasive disease. Wall Street analysts, on average, have forecast Prevnar 13 sales will reach $6.75 billion by 2016. The company reported sales of $941 million in the first quarter.
"While we view this (recommendation) as an incremental positive, we think the Street expected a positive outcome," ISI Group analyst Mark Schoenebaum said in a research note.
Pfizer shares were off 9 cents at $22.62 in midday trading on the New York Stock Exchange.
Prevnar 13 was initially approved by the U.S. Food and Drug Administration in 2010 for the prevention of invasive pneumococcal disease caused by the 13 serotypes included in the vaccine in infants and children from 6 weeks through 5 years old.
The FDA in December approved Prevnar 13 for adults age 50 and older. ACIP has not yet recommended the vaccine for that patient population.
"We are committed to continuing discussions with the ACIP with the aim of expanding the recommendations to include all adults 50 years of age and older - a population rapidly increasing in the United States and at risk for developing vaccine-type pneumococcal pneumonia and invasive disease," Pfizer said in a statement.
Pfizer is expecting data next year from a Prevnar 13 trial of more than 84,000 subjects 65 and older to determine if the vaccine is effective in preventing the first episode of community-acquired pneumonia caused by the 13 pneumococcal serotypes in the vaccine.
ACIP is likely awaiting results from that trial, called CAPITA, before making a recommendation for the vaccine's use in older adults.
"The key event for Prevnar 13 remains the data readout in 2013 from the CAPITA adult outcomes study," Schoenebaum said.
The vaccine is not approved for those between the ages of 6 and 49.
(Reporting By Bill Berkrot; editing by Maureen Bavdek and Andre Grenon)
TSC causes non-cancerous tumors of the brain, kidney and other organs, the FDA said. The disease affects up to 40,000 people in the United States, and as many as 80 percent develop kidney problems.
Afinitor helps suppress these tumors by blocking a protein that's essential for their development and growth, the FDA said.
The drug's safety and effectiveness were clinically evaluated among 118 people with TSC. The most common side effects were inflamed or sore mouth, nausea and vomiting, acne, eczema, cough, headache, diarrhea, abdominal pain, joint pain and swelling of the legs or arms. Some 15 percent of females who took Afinitor missed at least one menstrual period.
Afinitor was first approved by the FDA in 2009 to treat kidney tumors that weren't treated successfully with other drugs.
Afinitor is produced by Novartis, based in East Hanover, N.J.
More information
To learn more about this drug, visit the U.S. National Cancer Institute.
