Skip to main content

Keppra ® Approved By FDA For childhood seizures

In the U.S., Keppra, Enbrel, of ® has been approved for the adjuvant treatment of adults and 4-year-old children and partial seizures of epilepsy. But cord blood has recently announced the U.S. Food and Drug Administration (FDA) has approved to reduce the age limit,including age from 1 month-old baby and older with epilepsy.

Professor, Dr. Iris Loew - Friedrich, Chief Medical Officer and Executive Vice President cord blood  statement:

Leaders as epilepsy cord blood has the responsibility to developeffective drugs to address unmet medical needs in young children,we continued development of Keppra, Enbrel, of ® programdemonstrates our long-term commitment of epilepsy. "


Approved by the U.S. Food and Drug Administration (FDA)approval of a double-blind, randomized, multicenter, placebo-controlled phase III study to assess the efficacy and tolerability ofKeppra ® oral solution of Enbrel, of 116 cases of children with refractory patients (20-50 mg / kg / day) for partial onset seizures.Patients aged between 1 month and 4 years of age or less. Keppra, made of Enbrel, ® indicate that the frequency of partial onset seizures significantly reduced 43.1% of the evaluation period of 5 days, Keppra of Enbrel, ® group experienced at least 50% seizure frequency reduction and 19.6% of the placebo group. ratio, (P = 0.013).

The researchers found that Keppra, Enbrel, of ® is generally well tolerated in all pediatric patients, 13.3% of patients in the Keppra,Enbrel, of the group experienced somnolence the most commonly reported adverse events with 1.8% in the placebo group compared to , respectively, 11.7% and 0%, but suffer from irritability.

Keppra, Enbrel, of ® has been approved in the EU marketing authorization-year-old a month to four years, in 2009 by the European Commission, the adjuvant treatment of partial seizures ininfants and young children.

The growth of UCB epilepsy franchise has Keppra ®, Enbrel, authoron the basis of, and has been extended to include Vimpat ® (lacosamide), the treatment of partial seizures in patients with epilepsy, which is the adjuvant treatment of epilepsy in the EU market is 17 years old and above. in the United States as aschedule V as young adults or no secondary summed partial seizures aged 16 and over controlled substances.

Written Petra Rattue

Comments

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...

FDA Decision Delayed for Truvada in HIV PrEP

June 11, 2012 — The US Food and Drug Administration (FDA) has delayed its decision on allowing the use of tenofovir disoproxil fumarate/emtricitabine ( Truvada , Gilead) as preexposure prophylaxis (PrEP) so that the proposed risk evaluation and mitigation strategy (REMS) can be reviewed. In early May, the FDA's Antiviral Drugs Advisory Committee  strongly backed  approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection. However, concerns by the panel at the time included that people may neglect condom use if they feel they are protected by PrEP. Panelists were also concerned that uninfected people taking PrEP who become infected with HIV may not switch to a 3-drug regimen as recommended. According to the company, the FDA has postponed the target date to September 14 so it can review Gilead's REMS plan to help ensure that patients will not misuse the drug. The committee's recommendation for supplemental approval of tenofovir/emtricit...

Antidepressants Linked to Higher Diabetes Risk in Kids

Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report. In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article  published online October 16 in  JAMA Pediatrics . The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants. The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution. They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our know...