Berikut ini adalah senyawa obat dan biologi yang disetujui FDA Amerika beredar di tahun 2016. Silahkan disimak informasi kunci obat baru dan biologi yang sudah disetujui beredar ini.
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Contributor Information
Author : Mary L Windle, PharmD
Editor-in-Chief, Medscape Drug Reference
References
U.S. Food and Drug Administration. Novel Drugs Summary 2016. January 4, 2017. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm
Ahren B, et al. Postprandial glucagon reductions correlate to reductions in postprandial glucose and glycated hemoglobin with lixisenatide treatment in type 2 diabetes mellitus: A Post Hoc Analysis. Diabetes Ther. 2016 Jun 18.
Yabe D, et al. Efficacy of lixisenatide in patients with type 2 diabetes: A post hoc analysis of patients with diverse β-cell function in the GetGoal-M and GetGoal-S trials. J Diabetes Complications. 2016 May 24.
Pfeffer MA, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57.
Edwards JE, et al. Exposure-response relationship of obeticholic acid for alkaline phosphatase and total bilirubin in patients with primary biliary cirrhosis. Presented at Digestive Disease Week. May 21, 2016. San Diego, CA.
Zeuzem S, et al. Grazoprevir–Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015;163(1):1-13.
Buti M, et al. Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE. Clin Infect Dis. 2016 Jan 1;62(1):32-6.
Foster GR, et al. Astral-2 and -3 Investigators. Sofosbuvir and velpatasvir for HCV genotypes 2 and 3 infection. N Engl J Med. 2015 Dec 31;373(27):2608-17.
Feld JJ, et al. Astral-1 Investigators. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med. 2015 Dec 31;373(27):2599-607.
Curry MP, et al. Astral-4 Investigators. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28.
Venclexta (venetoclax) prescribing information. AbbVie, Inc. North Chicago, IL. April 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf
U.S. Food and Drug Administration. FDA News Release: FDA grants accelerated approval to new treatment for advanced ovarian cancer. 2016 Dec 19. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm
Mulcahy N. FDA Approves Rucaparib for BRCA Ovarian Cancer. Medscape Medical News. WebMD Inc. 2016 Dec 19. Available at http://www.medscape.com/viewarticle/873451
Rubraca (rucaparib) prescribing information. Clovis Oncology, Inc. Boulder, CO. 2016 December. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf
Rosenberg JE, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 Mar 4. pii: S0140-6736(16)00561-4.
Tap WD, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97.
Odewole OA, et al. Recurrent prostate cancer detection with anti-3-[18F]FACBC PET/CT: comparison with CT. Eur J Nucl Med Mol Imaging. 2016 Apr 18.
Van Binnebeek S, et al. Comparison of diagnostic accuracy of (111)In-pentetreotide SPECT and (68)Ga-DOTATOC PET/CT: A lesion-by-lesion analysis in patients with metastatic neuroendocrine tumours. Eur Radiol. 2016 Mar;26(3):900-9.
Richardson PG, et al. Phase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failure. Blood. 2016 Jan 29.
A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Infantile-onset Spinal Muscular Atrophy - ENDEAR trial. Presented at the British Paediatric Neurology Association (BPNA) Annual Conference in January 2017. Clinical Trials.gov identifier: NCT02193074
Klein P, et al. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-98
Cummings J, et al. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40.
Kappos L, et al. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28.
Gold R, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75.
Mendell JR, et al. Eteplirsen for the treatment of Duchenne muscular dystrophy. Ann Neurol. 2013 Nov;74(5):637-47.
Mendell JR, et al. Longitudinal effect of eteplirsen versus historical control on ambulation in Duchenne muscular dystrophy. Ann Neurol. 2016 Feb;79(2):257-71.
Castro M, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66.
Anthim (obiltoxaximab) prescribing information. Elusys Therapeutics, Inc. Pine Brook, NJ. http://www.anthim.com/download/pdf/ANTHIM-prescribing-information.pdf
Kelly CP, et al. The monoclonal antibody, bezlotoxumab targeting C. difficile toxin B shows efficacy in preventing recurrent C. difficile infection (CDI) in patients at high risk of recurrence or of CDI-related adverse outcomes. Gastroenterology. 2016 150:4 SUPPL. 1 (S122). Presented at Digestive Disease Week May 21-24, 2016. San Diego. http://www.gastrojournal.org/article/S0016-5085(16)30516-9/abstract
Griffiths CE, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51.
Paller, AS, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503. http://www.jaad.org/article/S0190-9622(16)30330-9/pdf
Bisa juga download materi presentasi powerpoint nya disini
Contributor Information
Author : Mary L Windle, PharmD
Editor-in-Chief, Medscape Drug Reference
References
U.S. Food and Drug Administration. Novel Drugs Summary 2016. January 4, 2017. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm
Ahren B, et al. Postprandial glucagon reductions correlate to reductions in postprandial glucose and glycated hemoglobin with lixisenatide treatment in type 2 diabetes mellitus: A Post Hoc Analysis. Diabetes Ther. 2016 Jun 18.
Yabe D, et al. Efficacy of lixisenatide in patients with type 2 diabetes: A post hoc analysis of patients with diverse β-cell function in the GetGoal-M and GetGoal-S trials. J Diabetes Complications. 2016 May 24.
Pfeffer MA, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57.
Edwards JE, et al. Exposure-response relationship of obeticholic acid for alkaline phosphatase and total bilirubin in patients with primary biliary cirrhosis. Presented at Digestive Disease Week. May 21, 2016. San Diego, CA.
Zeuzem S, et al. Grazoprevir–Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015;163(1):1-13.
Buti M, et al. Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE. Clin Infect Dis. 2016 Jan 1;62(1):32-6.
Foster GR, et al. Astral-2 and -3 Investigators. Sofosbuvir and velpatasvir for HCV genotypes 2 and 3 infection. N Engl J Med. 2015 Dec 31;373(27):2608-17.
Feld JJ, et al. Astral-1 Investigators. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med. 2015 Dec 31;373(27):2599-607.
Curry MP, et al. Astral-4 Investigators. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28.
Venclexta (venetoclax) prescribing information. AbbVie, Inc. North Chicago, IL. April 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf
U.S. Food and Drug Administration. FDA News Release: FDA grants accelerated approval to new treatment for advanced ovarian cancer. 2016 Dec 19. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm
Mulcahy N. FDA Approves Rucaparib for BRCA Ovarian Cancer. Medscape Medical News. WebMD Inc. 2016 Dec 19. Available at http://www.medscape.com/viewarticle/873451
Rubraca (rucaparib) prescribing information. Clovis Oncology, Inc. Boulder, CO. 2016 December. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf
Rosenberg JE, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 Mar 4. pii: S0140-6736(16)00561-4.
Tap WD, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97.
Odewole OA, et al. Recurrent prostate cancer detection with anti-3-[18F]FACBC PET/CT: comparison with CT. Eur J Nucl Med Mol Imaging. 2016 Apr 18.
Van Binnebeek S, et al. Comparison of diagnostic accuracy of (111)In-pentetreotide SPECT and (68)Ga-DOTATOC PET/CT: A lesion-by-lesion analysis in patients with metastatic neuroendocrine tumours. Eur Radiol. 2016 Mar;26(3):900-9.
Richardson PG, et al. Phase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failure. Blood. 2016 Jan 29.
A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Infantile-onset Spinal Muscular Atrophy - ENDEAR trial. Presented at the British Paediatric Neurology Association (BPNA) Annual Conference in January 2017. Clinical Trials.gov identifier: NCT02193074
Klein P, et al. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-98
Cummings J, et al. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40.
Kappos L, et al. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28.
Gold R, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75.
Mendell JR, et al. Eteplirsen for the treatment of Duchenne muscular dystrophy. Ann Neurol. 2013 Nov;74(5):637-47.
Mendell JR, et al. Longitudinal effect of eteplirsen versus historical control on ambulation in Duchenne muscular dystrophy. Ann Neurol. 2016 Feb;79(2):257-71.
Castro M, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66.
Anthim (obiltoxaximab) prescribing information. Elusys Therapeutics, Inc. Pine Brook, NJ. http://www.anthim.com/download/pdf/ANTHIM-prescribing-information.pdf
Kelly CP, et al. The monoclonal antibody, bezlotoxumab targeting C. difficile toxin B shows efficacy in preventing recurrent C. difficile infection (CDI) in patients at high risk of recurrence or of CDI-related adverse outcomes. Gastroenterology. 2016 150:4 SUPPL. 1 (S122). Presented at Digestive Disease Week May 21-24, 2016. San Diego. http://www.gastrojournal.org/article/S0016-5085(16)30516-9/abstract
Griffiths CE, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51.
Paller, AS, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503. http://www.jaad.org/article/S0190-9622(16)30330-9/pdf
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