Health Headlines - September 8

Glaxo Cervical Cancer Vaccine Up for Approval

A panel of experts for the U.S. Food and Drug Administration could recommend approval next week of a cervical cancer vaccine from GlaxoSmithKline, the Associated Press reported Friday.

Called Cervarix, the vaccine blocked the human papilloma virus (HPV), which is responsible for most cases of cervical cancer, nearly 93 percent of the time, the FDA said in documents filed online.

Cervarix already is permitted in close to 100 other countries. The FDA delayed a decision on its use in the United States in 2007, saying it needed additional information, the AP said.

Side effects from the vaccine, such as soreness near the injection site, were mild, the data showed.

When an expert panel convenes on Wednesday, the FDA will ask if Cervarix should be approved for women and girls ages 10 to 25. The FDA usually follows the experts' advice.

In related news, the FDA says Gardasil, the Merck vaccine used to prevent cervical cancer in women, also blocks the viruses responsible for genital warts in men.

Gardasil prevented genital warts in patients 90 percent of the time, the FDA said in documents presented online, the AP reported. The vaccine apparently blocks two strains of HPV that cause genital growths on males.

Merck is seeking FDA approval of Gardasil for boys and men ages 16 to 26, and a panel of advisers will consider the request next week.

Gardasil was approved for women in 2006.

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ADHD Drug Approved for Children and Teens

The drug Intuniv (guanfacine) has been approved by the U.S. Food and Drug Administration to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in people aged 6 to 17, drug maker Shire Plc said Thursday.

The once-daily drug, to be available in 1-to-4 milligram strengths, is expected on pharmacy shelves in November, the company said in a news release. The way it works is unclear, but the drug is thought to directly engage receptors in the brain's prefrontal cortex, an area that has been linked to the disorder.

Intuniv is not a controlled substance and "has no known potential for abuse or dependence," Shire said. It cited statistics from the U.S. Centers for Disease Control and Prevention that some 4.4 million children in the United States have been diagnosed with ADHD.

In clinical testing, the most common adverse reactions to Intuniv included tiredness, abdominal pain, dizziness, a drop in blood pressure, dry mouth and constipation, the company said.

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One-Dose Swine Flu Vaccine Looks Promising

Hopeful news in the battle against the H1N1 swine flu emerged Thursday as European and Chinese researchers said they have developed swine flu vaccines that work with one dose, rather than two, potentially increasing the supply available for distribution.

Novartis, the Swiss drug maker, found that in a British trial of 100 people between 18 and 50 years old, participants had adequate protection two weeks after just one injection, the Associated Press reported.

In China, a swine flu vaccine was approved on Thursday, which also works with one dose, according to its maker, Sinovac Biotech Ltd.

"The pilot results are encouraging," Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, said in a statement. "This is important information for public health authorities who prepare for vaccination in the coming months with limited vaccine supply."

Scientists previously thought two doses would be necessary, which could have contributed to a vaccine shortage. The World Health Organization declared swine flu a pandemic in June, and last month it said efforts to create an effective vaccine were progressing slowly, which could limit supplies this fall, when a resurgence of swine flu is expected.

Although encouraged, health experts said additional trials of both vaccines are needed to determine if a single dose is enough. How these developments will affect the worldwide supply is still unclear, because Novartis' vaccine relies on cell culture, while most flu vaccines use chicken eggs.

The Novartis formula, like most European vaccines, also uses adjuvants, a chemical component intended to make the vaccine more efficient. Neither the United States nor Canada has licensed flu vaccines with adjuvants, and limited information exists on how they affect pregnant women and children, two groups considered at high risk in a pandemic, the AP said.

The Sinovac vaccine and some others being tested in China and the United States do not use adjuvants.