WHO Drug Information Vol. 25, No. 2, 2011

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Regulatory Action and NewsWHO Drug Information Vol. 25, No. 2, 2011The most commonly reported side effectsincluded stomatitis, rash, diarrhoea,fatigue, edema, abdominal pain, nausea,fever and headache.Afinitor® is also approved to treat patientswith advanced renal cell carcinomaafter they fail treatment with sunitinib orsorafenib, and patients with subependymalgiant cell astrocytoma associatedwith tuberous sclerosis who cannot betreated with surgery.Reference: FDA News Release, 6 May 2011at http://www.fda.govBoceprevir approvedfor hepatitis CUnited States of America — The Foodand Drug Administration (FDA) hasapproved boceprevir (Victrelis®) to treatcertain adults with chronic hepatitis C.Boceprevir is used for patients who stillhave some liver function and who eitherhave not been previously treated withdrug therapy for hepatitis C or who havefailed such treatment. Boceprevir isapproved for use in combination withpeginterferon alfa and ribavirin.Safety and effectiveness of boceprevirwas evaluated in two phase III clinicaltrials with 1500 adult patients. In bothtrials, two-thirds of patients receivingboceprevir in combination with pegylatedinterferon and ribavirin experienced asignificantly increased sustained virologicresponse.According to the US Centers for DiseaseControl and Prevention, about 3.2 millionpeople in the United States have chronichepatitis C. Most liver transplants performedin the United States are due toprogressive liver disease caused byhepatitis C virus infection.Reference: FDA News Release, 13 May 2011at http://www.fda.govLinagliptin approvedfor type 2 diabetesUnited States of America — The Foodand Drug Administration (FDA) hasapproved linagliptin (Tradjenta®) tabletsfor use with diet and exercise, to improveblood glucose control in adults with Type2 diabetes which is the most commonform of the disease, affecting between 90and 95% of the 24 million diabetics in theUnited States.Linagliptin was demonstrated to be safeand effective in eight double-blind, placebo-controlledclinical studies involvingabout 3800 patients with Type 2 diabetes.Linagliptin has been studied as a standalonetherapy and in combination withother type 2 diabetes therapies includingmetformin, glimepiride, and pioglitazone.Linagliptin has not been studied in combinationwith insulin, and should not beused to treat people with type 1 diabetesor in those who have diabetic ketoacidosis.Reference: FDA News Release, 2 May 2011at http://www.fda.govNaproxcinod: withdrawal ofmarketing authorizationapplicationEuropean Union — The EuropeanMedicines Agency (EMA) has beennotified by the manufacturer of its decisionto withdraw its application for acentralized marketing authorization forthe medicine naproxcinod (Beprana®),375 mg hard capsules.Naproxcinod was intended to be used forthe relief of the signs and symptoms ofosteoarthritis of the knee and hip inadults.In its official letter, the company statedthat their decision to withdraw the appli-124
WHO Drug Information Vol. 25, No. 2, 2011Regulatory Action and Newscation was based on the fact that theCommittee for Medicinal Products forHuman Use (CHMP) considers that thedata provided do not allow it to concludeon a positive benefit-risk balance.Reference: EMA Press Release, EMA/322628/2011, 20 April 2011 at http://www.ema.euLumiracoxib: withdrawal ofmarketing authorizationapplicationEuropean Union — The EuropeanMedicines Agency (EMA) has beennotified by the manufacturer of its decisionto withdraw its application for acentralized marketing authorization forthe medicine lumiracoxib (Joicela®) 100mg film-coated tablets. Lumiracoxib wasintended to be used for symptomatic reliefin the treatment of osteoarthritis of theknee and hip in patients who are noncarriersof the DQA1*0102 allele.In its official letter, the company statedthat its decision to withdraw the applicationwas based on its inability to addressthe CHMP request to provide additionaldata within the timeframe allowed in thecentralized procedure.Reference: EMA Press Release, EMA/309990/2011, 18 April 2011 at http://www.ema.euErythropoietin: withdrawal ofmarketing authorizationapplicationEuropean Union — The EuropeanMedicines Agency (EMA) has beennotified by the manufacturer of its decisionto withdraw its application for acentralized marketing authorization forthe medicine erythropoietin (Epostim®),2000 IU/ 0.5 ml, 4000 IU/0.4 ml, and10 000IU/ml solution for injection in prefilledsyringes.This medicine was intended to be usedfor the following indications:• Treatment of anaemia associated withchronic renal failure in paediatric andadult patients on haemodialysis andadult patients on peritoneal dialysis.• Treatment of severe anaemia of renalorigin accompanied by clinical symptomsin adult patients with renal insufficiencynot yet undergoing dialysis.• Treatment of anaemia and reduction oftransfusion requirements in adultpatients receiving chemotherapy forsolid tumours, malignant lymphoma ormultiple myeloma.• To increase the yield of autologousblood from patients in a predonationprogramme.• To reduce exposure to allogenic bloodtransfusions in adult non-iron deficientpatients prior to major elective orthopaedicsurgery.In its official letter, the company statedthat its decision to withdraw the applicationwas based on its inability to addressthe CHMP’s request to provide additionaldata within the timeframe allowed in thecentralized procedure.Reference: EMA Press Release, EMA/271900/2011, 6 April 2011 at http://www.ema.eu125
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