Meningococcal vaccine Bexsero gets FDA approval
SILVER SPRING, Md. — The Food and Drug Administration last week announced approval for Bexsero, a vaccine intended to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 years through 25 years of age. Bexsero is the second vaccine approved by the FDA in the past three months to prevent the disease. The first was approved in October 2014.
Meningococcal disease is a life-threatening illness caused by bacteria that can infect the bloodstream, as well as the lining that surrounds the brain and spinal cord. The bacteria are transmitted person to person through respiratory or throat secretions. The Centers for Disease Control and Prevention says that close to 500 cases of meningococcal disease were reported in the United States in 2012. Out of those cases, 160 were caused by serogroup B.
“With today’s approval of Bexsero, the U.S. now has two vaccines for the prevention of serogroup B meningococcal disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”
Meningococcal disease can be treated with antibiotics to reduce the risk of death and long-term complications, but even then these outcomes are not always prevented. Vaccination is the most effective way to prevent the disease, the FDA said.
Bexsero is manufactured by Novartis Vaccines and Diagnostics Inc.
FDA grants approval to Natpara
SILVER SPRING, Md. — The Food and Drug Administration last week approved Natpara (parathyroid horomone), which is indicated to control hypocalcemia — low blood calcium levels — in patients who have hypoparathyroidism.
Hypoparathyroidism happens when the body secretes abnormally low levels of parathyroid hormone, which plays an important role in regulating calcium and phosphorus levels in the body. The disease affects 60,000 people in the United States, according to the FDA.
Patients who have hypoparathyroidism may experience numbness, tingling, muscle twitching, spasms or cramps, abnormal heart rhythm and seizures resulting from low blood calcium levels. The disease is also associated with such long-term complications as kidney damage, kidney stones, cataracts and soft tissue calcification. Natpara is injected once a day, and helps to regulate the body's calcium levels. The FDA has given the medication and orphan drug designation because it is used to treat a rare disease.
“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life,” said Jean-Marc Guettier, M.D., director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research. “This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D.”
Natpara is manufactured by NPS Pharmaceuticals.
Purdue Pharma launches Hysingla ER
STAMFORD, Conn. — Purdue Pharma on Monday announced the launch of Hysingla ER (hydrocodone bitartrate) extended-release tablets CII. According to the company, the once-daily drug is the first and only hydrocodone product to be recognized by the Food and Drug Administration as having properties that deter misuse and abuse via chewing, snorting and injection — though abuse of the drug through intravenous, intranasal and oral routes is still possible.
“Acetaminophen toxicity and the misuse and abuse of opioids are real concerns among clinicians treating people with chronic pain,” said Bob Twillman, Ph.D., executive director at the American Academy of Pain Management. “The availability of a hydrocodone product with abuse-deterrent properties that does not contain acetaminophen gives healthcare professionals and chronic pain patients an important new treatment option.”
Hysingla ER received FDA approval in November 2014 and is available in 20-, 30-, 40-, 60-, 80-, 100- and 120-mg dosage strengths. Purdue is offering a patient trial card and copay support programs for eligible patients.
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