PHARMACY

FDA expands age range for meningitis vaccine

BY Allison Cerra

WASHINGTON Parents can ease their worries about their children contracting meningitis.

The FDA announced this week that they have broadened the age range of Sanofi Pasteur’s bacterial meningitis vaccine Menactra for children ages 2 to 10.

Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) is the only conjugate vaccine licensed in the U.S. to prevent meningococcal disease. The vaccine was approved originally in 2005 to immunize patients ages 11 to 55.

Sanofi Pasteur’s Menomune vaccine was previously the only meningococcal vaccine available in the U.S. for children ages 2 and older.

The vaccines protect against four of the five most common serogroups of the bacteria that cause meningococcal infection. Approximately half of meningitis cases in children ages 2 to 5 and two-thirds of cases in children ages 6 to 11 can be prevented through vaccination, according to University of Rochester Medical Center professor Michael Pichichero.

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FDA approves supplemental NDA for Januvia

BY Allison Cerra

WASHINGTON The FDA approved a supplemental new drug application for Merck’s Type 2 diabetes drug Januvia, citing new uses and additional warnings.

The pharmaceutical company, which produces several heart-related medications, had received feedback from patients taking Januvia (sitagliptin) experiencing health problems including anaphylaxis, angioedema and undesirable skin conditions. There had been reports that patients experienced the potentially fatal skin condition known as Stevens-Johnson Syndrome.

Januvia’s revised labeling will now indicate that patients with a history of hypertension should not use the drug. The company said, however, it could not establish a causal relationship to the drug or reliably estimate the frequency of the side effects.

The updated labeling additionally states that Januvia can be used as an initial therapy or add-on therapy with other medications, including metformin and sulfonylurea.

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House Dems push through revised SCHIP, but GOP claims partisanship

BY Allison Cerra

WASHINGTON The House of Representatives approved a new version of legislation to expand the State Children’s Health Insurance Program yesterday, but the vote failed to get any more Republicans to override another promised veto from President Bush.

Democratic leaders decided the new revision would state the exclusion of illegal immigrants from the program, which would motivate state governments to drop families earning more than 300 percent of the poverty line, which will ultimately force adults off of the program.

Under both versions, the combined average monthly enrollment in SCHIP and Medicaid would be about 34.1 million people, according to the Congressional Budget Office. But there is a shift toward serving poorer children, a key Republican demand. In the new bill, Medicaid enrollment alone would be about 400,000 individuals higher than under the vetoed bill, while SCHIP enrollment would be about that much lower, according to CBO documents.

Almost half of the 3.9 million uninsured children projected to gain coverage under the revised bill, of whom about 80 percent live below the poverty level, would be covered under Medicaid, said Genevieve Kenney, an Urban Institute health economist.

According to The Washington Post, the 265 to 142 tally included 43 Republicans, two fewer than the version that passed Sept. 25.

Republicans called for a postponement of the vote due to the absence of nine members House touring the wildfire disaster in California, but Speaker Nancy Pelosi, D-Calif., insisted she had no choice but to move forward and give the Senate a chance to send the measure to Bush next week. “If Republicans believe in SCHIP as they say they do . . . then they won’t be looking for an excuse to vote against the bill,” Pelosi said.

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