NOVEL PHARMACEUTICALS 2015
FDA Approvals of Brand-Name Prescription Drugs in 2015 The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications II. New Combinations and New Indications III. New Dosage Forms and New Formulations IV. New Biosimilars, Vaccines, Viral Therapies, and Blood Products
I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications Addyi (NME) (Flibanserin; Sprout Pharmaceuticals) Class/route: First-in-class serotonin agonist antagonist; oral Indication: For the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not caused by a coexisting medical or psychiatric condition, relationship problems, or the effects of a medication or other drug substance Approval consideration: REMS program Alecensa (NME) (Alectinib; Genentech) Class/route: ALK inhibitor; oral Indication: For the treatment of patients with ALK- positive metastatic NSCLC who have progressed while receiving crizotinib or are intolerant to it Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review Aristada (NME) (Aripiprazole lauroxil; Alkermes) Class/route: Atypical antipsychotic, extended-release; intramuscular injection Indication: For the treatment of adults with schizophrenia Approval consideration: Patient Medication Guide Avycaz (NME) (Ceftazidime and avibactam; Cerexa) Classes/route: Cephalosporin and beta-lactamase inhibitor; intravenous infusion
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Indications: For the treatment of complicated urinary tract infections in patients aged ≥18 years; in combination with metronidazole for the treatment of complicated intra-abdominal infections in patients aged ≥18 years Approval considerations: Fast track, priority review, QIDP Bridion (NME) (Sugammadex; Merck) Class/route: First-in-class selective relaxant binding agent; intravenous Indication: For the reversal of postsurgical neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults Approval consideration: Priority review Cholbam (NME) (Cholic acid; Asklepion Pharmaceuticals) Class/route: Bile acid; oral Indications: For the treatment of bile acid synthesis disorders resulting from single enzyme defects; for the adjunctive treatment of peroxisomal disorders, including Zellweger spectrum disorders, in patients with liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption Approval considerations: Orphan drug, priority review Corlanor (NME) (Ivabradine; Amgen) Class/route: First-in-class hyperpolarization-activated cyclic nucleotide-gated channel blocker; oral Indication: To reduce hospitalization risk from worsening heart failure in patients with stable, symptomatic chronic heart failure with left-ventricular ejection frac-
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NOVEL PHARMACEUTICALS 2015
tion ≤35% who are in sinus rhythm with a resting heart rate ≥70 bpm, and are receiving maximally tolerated doses of beta-blockers or who have a contraindication to beta-blockers Approval considerations: Fast track, priority review Cosentyx (BLA) (Secukinumab; Novartis) Class/route: First-in-class human IL-17A antagonist; subcutaneous injection Indications: For the treatment of adults with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; for active psoriatic arthritis; and for active ankylosing spondylitis Cotellic (NME) (Cobimetinib; Genentech) Class/route: Mitogen-activated protein kinase inhibitor/ extracellular signal 306 regulated kinase 1 and 2 inhibitor; oral Indication: For the treatment of unresectable or metastatic melanoma, in combination with vemurafenib, in patients with a BRAF V600E or BRAF V600K mutation Approval considerations: Fast track, orphan drug, priority review Cresemba (NME) (Isavuconazonium sulfate; Astellas Pharma) Class/route: Azole antifungal; oral/intravenous infusion Indications: For the treatment of invasive aspergillosis and for invasive mucormycosis Approval considerations: Orphan drug, priority review, QIDP Daklinza (NME) (Daclatasvir; Bristol-Myers Squibb) Class/route: HCV NS5A inhibitor; oral Indication: For the treatment, in combination with sofosbuvir, of chronic HCV genotype 3 infection Approval considerations: Fast track, priority review Darzalex (BLA) (Daratumumab; Janssen Biotech) Class/route: First-in-class human CD38-directed monoclonal antibody; intravenous Indication: For the treatment of patients with multiple myeloma who have received at least 3 previous lines of therapy including a proteasome inhibitor and an immunomodulatory agent and for those whose disease is double-refractory to a proteasome inhibitor and to an immunomodulatory agent Approval considerations: Accelerated approval, breakthrough therapy, fast track, orphan drug, priority review
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Empliciti (BLA) (Elotuzumab; Bristol-Myers Squibb) Class/route: First-in-class SLAMF7-directed immunostimulatory antibody; intravenous infusion Indication: For the treatment, in combination with lenalidomide and dexamethasone, of patients with multiple myeloma who have received 1 to 3 previous therapies Approval considerations: Breakthrough therapy, orphan drug, priority review Entresto (NME) (Sacubitril and valsartan; Novartis) Classes/route: First-in-class neprilysin inhibitor and angiotensin II receptor blocker; oral Indication: For risk reduction of cardiovascular death or hospitalization caused by heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction Approval considerations: Fast track, priority review Farydak (NME) (Panobinostat; Novartis) Class/route: Histone deacetylase inhibitor; oral Indication: For the treatment, in combination with bortez omib and dexamethasone, of patients with multiple myeloma who have received at least 2 previous regimens, including bortezomib and an immunomodulatory agent Approval considerations: Accelerated approval, orphan drug, priority review, REMS program Genvoya (NME) (Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; Gilead Sciences) Classes/route: HIV-1 integrase strand transfer inhibitor, a cytochrome P3A inhibitor, and HIV-1 nucleoside analog reverse transcriptase inhibitors; oral Indication: A complete regimen for the treatment of patients aged ≥12 years with HIV-1 infection and no antiretroviral treatment history, or to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA
FDA Approvals of Brand-Name Prescription Drugs in 2015 The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications II. New Combinations and New Indications III. New Dosage Forms and New Formulations IV. New Biosimilars, Vaccines, Viral Therapies, and Blood Products
I. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications Addyi (NME) (Flibanserin; Sprout Pharmaceuticals) Class/route: First-in-class serotonin agonist antagonist; oral Indication: For the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not caused by a coexisting medical or psychiatric condition, relationship problems, or the effects of a medication or other drug substance Approval consideration: REMS program Alecensa (NME) (Alectinib; Genentech) Class/route: ALK inhibitor; oral Indication: For the treatment of patients with ALK- positive metastatic NSCLC who have progressed while receiving crizotinib or are intolerant to it Approval considerations: Accelerated approval, breakthrough therapy, orphan drug, priority review Aristada (NME) (Aripiprazole lauroxil; Alkermes) Class/route: Atypical antipsychotic, extended-release; intramuscular injection Indication: For the treatment of adults with schizophrenia Approval consideration: Patient Medication Guide Avycaz (NME) (Ceftazidime and avibactam; Cerexa) Classes/route: Cephalosporin and beta-lactamase inhibitor; intravenous infusion
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Indications: For the treatment of complicated urinary tract infections in patients aged ≥18 years; in combination with metronidazole for the treatment of complicated intra-abdominal infections in patients aged ≥18 years Approval considerations: Fast track, priority review, QIDP Bridion (NME) (Sugammadex; Merck) Class/route: First-in-class selective relaxant binding agent; intravenous Indication: For the reversal of postsurgical neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults Approval consideration: Priority review Cholbam (NME) (Cholic acid; Asklepion Pharmaceuticals) Class/route: Bile acid; oral Indications: For the treatment of bile acid synthesis disorders resulting from single enzyme defects; for the adjunctive treatment of peroxisomal disorders, including Zellweger spectrum disorders, in patients with liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption Approval considerations: Orphan drug, priority review Corlanor (NME) (Ivabradine; Amgen) Class/route: First-in-class hyperpolarization-activated cyclic nucleotide-gated channel blocker; oral Indication: To reduce hospitalization risk from worsening heart failure in patients with stable, symptomatic chronic heart failure with left-ventricular ejection frac-
www.AHDBonline.com
Vol 9
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Special Feature
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March 2016
NOVEL PHARMACEUTICALS 2015
tion ≤35% who are in sinus rhythm with a resting heart rate ≥70 bpm, and are receiving maximally tolerated doses of beta-blockers or who have a contraindication to beta-blockers Approval considerations: Fast track, priority review Cosentyx (BLA) (Secukinumab; Novartis) Class/route: First-in-class human IL-17A antagonist; subcutaneous injection Indications: For the treatment of adults with moderate- to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; for active psoriatic arthritis; and for active ankylosing spondylitis Cotellic (NME) (Cobimetinib; Genentech) Class/route: Mitogen-activated protein kinase inhibitor/ extracellular signal 306 regulated kinase 1 and 2 inhibitor; oral Indication: For the treatment of unresectable or metastatic melanoma, in combination with vemurafenib, in patients with a BRAF V600E or BRAF V600K mutation Approval considerations: Fast track, orphan drug, priority review Cresemba (NME) (Isavuconazonium sulfate; Astellas Pharma) Class/route: Azole antifungal; oral/intravenous infusion Indications: For the treatment of invasive aspergillosis and for invasive mucormycosis Approval considerations: Orphan drug, priority review, QIDP Daklinza (NME) (Daclatasvir; Bristol-Myers Squibb) Class/route: HCV NS5A inhibitor; oral Indication: For the treatment, in combination with sofosbuvir, of chronic HCV genotype 3 infection Approval considerations: Fast track, priority review Darzalex (BLA) (Daratumumab; Janssen Biotech) Class/route: First-in-class human CD38-directed monoclonal antibody; intravenous Indication: For the treatment of patients with multiple myeloma who have received at least 3 previous lines of therapy including a proteasome inhibitor and an immunomodulatory agent and for those whose disease is double-refractory to a proteasome inhibitor and to an immunomodulatory agent Approval considerations: Accelerated approval, breakthrough therapy, fast track, orphan drug, priority review
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March 2016
Empliciti (BLA) (Elotuzumab; Bristol-Myers Squibb) Class/route: First-in-class SLAMF7-directed immunostimulatory antibody; intravenous infusion Indication: For the treatment, in combination with lenalidomide and dexamethasone, of patients with multiple myeloma who have received 1 to 3 previous therapies Approval considerations: Breakthrough therapy, orphan drug, priority review Entresto (NME) (Sacubitril and valsartan; Novartis) Classes/route: First-in-class neprilysin inhibitor and angiotensin II receptor blocker; oral Indication: For risk reduction of cardiovascular death or hospitalization caused by heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction Approval considerations: Fast track, priority review Farydak (NME) (Panobinostat; Novartis) Class/route: Histone deacetylase inhibitor; oral Indication: For the treatment, in combination with bortez omib and dexamethasone, of patients with multiple myeloma who have received at least 2 previous regimens, including bortezomib and an immunomodulatory agent Approval considerations: Accelerated approval, orphan drug, priority review, REMS program Genvoya (NME) (Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; Gilead Sciences) Classes/route: HIV-1 integrase strand transfer inhibitor, a cytochrome P3A inhibitor, and HIV-1 nucleoside analog reverse transcriptase inhibitors; oral Indication: A complete regimen for the treatment of patients aged ≥12 years with HIV-1 infection and no antiretroviral treatment history, or to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA
