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FDA advisory committee votes to extend use of pneumococcal vaccine to adults
FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement.
FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement. The vote of the 15-member panel was 14 in favor and 1 against.
If approved by FDA, Prevnar 13, which is now approved only for use in children, will become the first and only pneumococcal conjugate vaccine approved for adults in the United States. Currently, Pfizer’s supplemental biologics license application (sBLA) is under FDA review, with agency action expected in January.
FDA will consider the committee’s favorable recommendation, although not binding, in its final review of the sBLA for the vaccine. If approved, FDA will determine final prescribing information.
FDA granted Pfizer an “accelerated approval designation” for its sBLA, a decision that reflects the high rate of life-threatening pneumococcal pneumonia in adults aged 50 years and older, and it is based on the potential of Prevnar 13 to provide clinical benefit over the currently available nonconjugated pneumococcal polysaccharide vaccine.
The advisory committee’s votes in support of Prevnar 13 were based on a review of immunogenicity data from Phase 3 clinical studies involving more than 6,000 adults aged 50 years and older.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
