Biotechnology Healthcare - November/December 2008 - (Page 15) SELECTED FDA BIOLOGIC DRUG APPROVALS, AUGUST–SEPTEMBER 2008 Action date Manufacturer Drug (trade name) Indication Administration Biologics license approval Aug. 22, 2008 Amgen romiplostim (Nplate) Patients with ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy Subcutaneous injection New indication Sept. 12, 2008 Talecris Biotherapeutics IGIV (human), 10% (Gamunex) CIDP Intravenous infusion SELECTED FDA ACTIONS, AUGUST–SEPTEMBER 2008 Manufacturer GTC Biotherapeutics Drug (trade name) ATIII (ATryn) Type of drug Recombinant antithrombin Indication sought Hereditary antithrombin deficiency Hereditary angioedema Notes BLA filed Aug. 7; accepted Oct. 6;* priority review granted BLA filed Sept. 24 Biologics license application (BLA) Dyax Fast-track designation Proteon Therapeutics ecallantide, formerly DX- Selective plasma 88 kallikrein inhibitor PRT-201 Recombinant human elastase Improve vascular Granted Sept. 10 access for hemodialysis Orphan drug designation Stromedix Vivendy Therapeutics Denials or delays Roche tocilizumab (Actemra) Ad5CMV-p53 (Advexin) IL-6 receptor-inhibitor Rheumatoid arthritis Approval delayed, FDA seeks manufacturing information “Complete response” letter issued Sept. 2 STX-100 enzyme replacement therapy Humanized monoclonal antibody Recombinant human enzyme Chronic allograft nephropathy Morbus morquio Granted Aug. 12 Granted Sept. 17 Introgen Therapeutics p53 tumor suppressor (gene therapy) Recurrent, refractory head and neck cancer *Ovation Pharmaceuticals acquired the license for commercialization of ATryn from GTC on Aug. 14. CIDP=chronic inflammatory demyelinating polyneuropathy, IGIV=immune globulin (intravenous), IL=interleukin, ITP=chronic immune thrombocytopenic purpura. Sources: FDA, manufacturers’ news releases and package inserts, U.S. Securities and Exchange Commission filings received a combination of GVAX and docetaxel chemotherapy died, compared to 47 who were given docetaxel alone. Cell Genesys ended development of the program and laid off most of its employees. FDA actions The FDA has begun a new system for responding to new drug applications. Instead of the former “approvable” and “not approvable” letters, the agency now issues “complete response” letters. Complete response letters communicate what manufacturers need to do to achieve approval. The FDA says this provides more consistent responses to manufacturers, but investors say it gives less insight into a drug’s prospects for approval. Only the company that receives a letter can disclose its contents — and decide how to frame the information. Using power Congress granted it last year, the FDA called for new uniform boxed warnings about histoplasmosis and other fungal infections on the labels of four TNF-α blockers: infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), and etanercept. The FDA reviewed 240 reported cases of histoplasmosis in patients taking the drugs. Of those, 45 people died and 21 cases were not promptly diagnosed, leading to delayed treatment. The FDA urges physicians to take precautions when prescribing TNF-α blockers to patients vulnerable to fungal infections. Did you hear? Two multiple sclerosis patients in Europe taking natalizumab (Tysabri) contracted progressive multifocal leukoencephalopathy — the first cases of PML since the drug’s reintroduction. Natalizumab, which was originally developed as an MS drug and has since has received an FDA indication for Crohn’s disease, is now under study in patients with multiple myeloma. NOVEMBER/DECEMBER 2008 · BIOTECHNOLOGY HEALTHCARE 15
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