Posted by djmmm on February 2, 2007, at 12:44:12
from Medscape:
International Approvals: Keppra, NeoRecormon, Wellbutrin XR
Yael WaknineJanuary 19, 2007 — The European Commission has approved levetiracetam for the adjunctive treatment of primary generalized tonic-clonic seizures in patients aged 12 years and older with refractory idiopathic generalized epilepsy, and epoetin beta 30,000 IU once-weekly subcutaneous injection for the treatment of symptomatic anemia in adult patients with solid cancers receiving any form of chemotherapy. The Netherlands' Medicines Evaluation Board has approved bupropion HCl modified-release tablets for the treatment of major depressive disorder in adults.
Levetiracetam (Keppra) for Primary Generalized Tonic-Clonic Seizures in EUOn January 16, the European Commission (EC) approved a new indication for levetiracetam (Keppra, made by made by UCB Group), allowing its use in the adjunctive treatment of primary generalized tonic-clonic seizures in patients aged 12 years and older with idiopathic generalized epilepsy (IGE).
The approval was based on data from a phase 2, 24-week, placebo-controlled, double-blind study (n = 164) that evaluated the benefit of adding levetiracetam to usual therapy for controlling refractory IGE (baseline, 3 or more primary generalized tonic-clonic seizures during an 8-week period) in patients aged 4 to 65 years. Patients randomized to receive levetiracetam were uptitrated for 4 weeks to a target dose of 3000 mg/day (60 mg/kg/day for pediatric patients) and then evaluated for 20 weeks.
Results showed that the addition of levetiracetam decreased weekly seizure rates by 50% or more in 72.2% of patients compared with 45.2% of those receiving usual therapy alone (P < .001) Seizure-free rates were also significantly increased in the levetiracetam group (24.1% vs 7.1%; P = .004).
Long-term study data showed that of patients who continued receiving adjunctive treatment with levetiracetam, 47.4% were seizure-free at 6 months and 31.5% were seizure-free at 1 year.
According to a company news release, the drug was well-tolerated in the study, fatigue being the most commonly reported adverse event.
Levetiracetam was previously approved by the EC and US Food and Drug Administration as adjunctive therapy for partial-onset seizures with or without secondary generalization in epileptic patients aged 4 years and older, and as adjunctive therapy for myoclonic seizures in patients aged 12 years and older with juvenile myoclonic epilepsy.
An additional EC indication allows the use of levetiracetam as first-line monotherapy for the treatment of partial-onset seizures with or without secondary generalization in patients aged 16 years and older.
Epoetin Beta Once-Weekly Injection (NeoRecormon) for Anemic Patients with Solid Tumors in EUOn January 16, the European Commission (EC) approved an expanded indication for epoetin beta 30,000 IU subcutaneous injection (NeoRecormon, made by Roche), allowing its once-weekly use for the treatment of symptomatic anemia in adult patients with solid cancers receiving any form of chemotherapy. Previously, cancer patients were required to undergo injections of the product 3 times per week.
According to a company news release, the regimen is expected to make treatment more manageable for cancer patients receiving chemotherapy, up to 95% of whom develop anemia either as a result of the cancer itself or as a consequence of treatment.
The company notes that the once-weekly product has been shown to effectively and rapidly correct anemia irrespective of the type of chemotherapy administered. In addition, it reduces the need for blood transfusions by at least 50% compared with standard care and significantly increases the time to first transfusion. Patients often experience improved quality of life and increased daily energy levels.
The approval was primarily based on data from the Breast cancer – Anemia and the Value of Erythropoietin (BRAVE) study of women with metastatic breast cancer receiving chemotherapy, and the NAUTICA study of patients undergoing chemotherapy for a wide range of cancers.
The once-weekly epoetin beta regimen was previously approved by the EC for the treatment of anemia in patients receiving anti-tumor therapy for lymphoid cancers, including multiple myeloma, low-grade non-Hodgkin's lymphoma and chronic lymphocytic leukemia.
Bupropion HCl Modified-Release Tablets (Wellbutrin XR) for Depression in the NetherlandsOn January 16, the Netherlands' Medicines Evaluation Board approved bupropion HCl 150- and 300-mg modified-release tablets (Wellbutrin XR, made by Biovail Corp and marketed by GlaxoSmithKline) for the treatment of major depressive disorder (MDD) in adults. The recommended initial dose is 150 mg daily, to be uptitrated to a maximum dose of 300 mg/day as required.
According to a company news release, the product is also considered approvable by the regulatory agencies of 21 other countries under the decentralized procedure: Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.
Bupropion 150- and 300-mg tablets (made and marketed as Wellbutrin XL by GlaxoSmithKline) were previously approved by the US Food and Drug Administration for the treatment of MDD and seasonal affective disorder.
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