PHARMACY

FDA allows emergency use of still-unapproved vaccine against deadly meningitis amid Princeton University outbreak

BY Alaric DeArment

CAMBRIDGE, Mass. — Swiss drug maker Novartis is providing a vaccine to Princeton University amid an outbreak of potentially fatal meningitis that has affected at least eight students, the university said Monday.

Princeton said it had started a vaccination program with Novartis’ Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed]). Bexsero currently has approval in Canada, Europe and Australia, and the Food and Drug Administration gave it conditional approval in response to an application from the Centers for Disease Control and Prevention for its use on the Princeton campus to protect students against the infection. It is currently in phase-1 and phase-2 clinical trials in the United States, but is being recommended for all Princeton undergraduate students, whether they live on- or off-campus, as well as graduate students living in dormitories.

Meningococcal serogroup B, also known as MenB, is a rare but devastating infection that progresses rapidly and can lead to death or permanent disability within 24 hours of symptom onset. It can be difficult for healthcare professionals to diagnose in its early stages because symptoms are often non-specific and flu-like, but one-tenth of those with the disease die despite treatment, and among those who survive, one-fifth suffer from lifelong disabilities such as brain damage, hearing loss and limb loss.

 

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Upsher-Smith gets promising results from phase-3 trial of epilepsy drug

BY Alaric DeArment

MAPLE GROVE, Minn. — An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

The drug maker presented results of the phase-3 "PREVAIL" trial of USL255 at the American Epilepsy Society’s 67th Annual Meeting in Washington, which started Friday and ends Tuesday. USL255, an extended-release formulation of the drug topiramate, showed a significantly greater reduction in the frequency of weekly partial-onset seizures than placebo after 11 weeks of treatment, and side effects were generally resolved over time. Nearly all of the patients who finished the first part of the trial have elected to continue in a year-long extension study of the drug.

"Topiramate is a well-known, effective agent for the treatment of a variety of seizure disorders, but many patients experience challenging cognitive side effects while taking the immediate-release formulation of the drug," Barrow Neurological Institute of Phoenix professor of neurology and trial investigator Steve Chung said. "The PREVAIL trial showed that USL255, a once-daily, extended-release formulation of topiramate, is efficacious across a range of seizure types and patient severity."

 

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Reports: Patients reported as cured of HIV experience return of virus

BY Alaric DeArment

NEW YORK — Two patients in Boston whom researchers had thought were cured of HIV have experienced a relapse of the infection, according to published reports.

The New York Daily News reported that the two men, who were believed cured after receiving bone marrow transplants for lymphoma, had the virus return.

In both patients, the virus had been reduced to undetectable levels, and they had stopped taking antiretroviral drugs for HIV. But due to latently infected cells, often called "reservoirs," the virus was able to return and the two have resumed taking drugs for it. Another patient, Timothy Ray Brown, received a bone marrow transplant in 2007 in Berlin from a patient with a rare genetic mutation that makes people resistant to the virus and has apparently remained cured, according to reports.

 

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