Biotechnology Healthcare - June 2008 - (Page 10) DRUG TRACK SELECTED FDA BIOLOGIC DRUG-RELATED ACTIONS, NOV. 2007–MARCH 2008 Manufacturer Drug name (Trade name) Type of drug Indication Notes Biologic license applications Roche Schering-Plough tocilizumab (Actemra) peginterferon alfa-2b (PEGIntron) (sBLA) ustekinumab (formerly CNTO-1275) certolizumab pegol (Cimzia) mAB, inhibits IL-6 Recombinant alfa interferon mAB, targets IL-12 and IL-23 Peg-antiTNF-α antibody fragment Reduce signs and symptoms in adults with moderate to severe rheumatoid arthritis Stage III malignant melanoma Filed Nov. 21, 2007 Accepted and priority review granted Jan. 31, 2008 Accepted Feb. 4, 2008 Centocor/ Janssen-Cilag UCB Adults with chronic moderate to severe plaque psoriasis Adults with active rheumatoid arthritis Accepted Feb. 6, 2008 New drug application Cephalon bendamustine (Treanda) Chemotherapy agent Indolent B-cell NHL in patients who have progressed during or following treatment with rituximab or a rituximab-containing regimen Accepted Feb. 19, 2008 Orphan drug designations GlaxoSmithKline/ Synta Pharmaceuticals elesclomol (formerly STA-4783) Novel injectable; Metastatic melanoma kills cancer cells by elevating oxidative stress levels Chemosensitizing agent Granted Jan. 28, 2008 Marshall Edwards triphendiol (formerly NV-196) Late-stage pancreatic and bile duct cancers Granted Feb. 19, 2008 IL=interleukin, mAB=monoclonal antibody, NHL=non-Hodgkin’s lymphoma, sBLA=supplemental biologic license application. Sources: FDA, Manufacturers’ news releases its immunotherapy for nonHodgkin’s lymphoma, it will have to conduct another trial. MyVax failed to halt disease progression in its pivotal phase 3 trial, and the FDA was unimpressed by gains in a subset of the trial population. … After Unither Pharmaceuticals’ oregovomab (OvaRex) failed to meet primary endpoints in two phase 2 studies of ovarian cancer patients, Unither ceased development of all five of its monoclonal antibodies. The FDA approved revised boxed warnings for darbepoetin alfa (Aranesp), epoetin alfa (Epogen), and epoetin alfa (Procrit) to include a statement that symptoms of anemia, fatigue, and quality of life have not been shown to improve in patients with cancer who are treated with erythropoiesisstimulating agents (ESAs). … An FDA advisory panel recommended that ESAs not be prescribed to patients with advanced breast and head and neck cancers, but did not vote to withdraw their FDA approval for chemotherapy-induced anemia. Another FDA advisory panel has recommended approval of Amgen’s romiplostim (Nplate) therapy for thrombocytopenia in adults with chronic idiopathic thrombocytopenic purpura (ITP). The panel also endorsed the company’s recommendations that Amgen track patients receiving romiplostim and report adverse events to the FDA, and that physicians be required to certify that a patient has ITP before prescribing the drug. The FDA has extended the deadline for its priority review of romiplostim to July 23. … The San Francisco Chronicle reports that the FDA is close to approving seven biomarkers that would signal kidney injury during clinical trials, and would require that biomarker test results be included in new drug applications. A meta-analysis of randomized controlled trials published in Annals of the Rheumatic Diseases concludes that anakinra (Kineret) may increase the risk for serious infections in patients with RA, especially in those with comorbidities. … A study published in the New England Journal of Medicine reported that proteinuria results when bevacizumab inhibits the normal growth of blood vessels in the kidney. More studies are necessary to determine the incidence and severity of kidney damage in patients receiving bevacizumab, and which patients are most at risk. … Biogen Idec and Elan posted a letter on the FDA’s Web site warning physicians of possible severe liver damage in some MS patients treated with natalizumab (Tysabri). … Imatinib (Gleevec), Novartis’s tyrosine kinase inhibitor, has been reformulated so that it no longer interferes with kinases that contribute to organ system development. 10 BIOTECHNOLOGY HEALTHCARE · MAY/JUNE 2008
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