BETHESDA, MD 29 January 2010—Thirty-seven new molecular entities, vaccines, and blood products won FDA marketing approval last year, up from 34 in the previous year. Highlights of the approved products appear below, and a full list of new products and their indications appears below.
What`s old is new again. A reformulated version of Creon pancrelipase oral capsules from Solvay Pharmaceuticals was approved in April, making the product the only FDA-sanctioned prescription pancreatic enzyme replacement product on the U.S. market. Creon is indicated for the treatment of exocrine pancreatic insufficiency in people with cystic fibrosis or other conditions.
Pancreatic enzyme replacement products have been sold for decades without FDA`s review and approval of the formulations. FDA announced in 2004 that all makers of unapproved pancreatic insufficiency products, except for dietary supplements, must submit marketing applications to the agency or pull the medications from the market. Manufacturers have until April 28 to earn FDA approval for their current pancrelipase products.
New cancer treatments. Everolimus, an inhibitor of the mammalian target of rapamycin, and pazopanib, an inhibitor of several growth factors and cytokines, are two new therapies indicated for the treatment of advanced renal cell carcinoma. Everlomus was approved in March and is sold as Afinitor by Novartis. Pazopanib, marketed as Votrient by GlaxoSmithKline, was approved in October.
A second GlaxoSmithKline cancer chemotherapy drug, ofatumumab, was also approved in October. Marketed as Arzerra, the product is a CD-20-binding monoclonal antibody indicated as a second-line treatment for chronic lymphocytic leukemia.
Pralatrexate, a folate analogue metabolic inhibitor sold by Allos Therapeutics under the brand name Folotyn, was approved in September as a second-line treatment for peripheral T-cell lymphoma.
Romidepsin, or Istodax, from Gloucester Pharmaceuticals, is a histone deacetylase inhibitor that was approved in November. The product is a second-line therapy for patients with cutaneous T-cell lymphoma.
Two for schizophrenia. Last year marked the approval of two new orally administered atypical antipsychotics for the treatment of schizophrenia.
Iloperidone, sold as Fanapt by Vanda Pharmaceuticals, was approved in May. Saphris, an asenapine maleate product from Organon, was approved in August. Asenapine is also indicated for the treatment of manic or mixed episodes associated with bipolar I disorder.
Vaccines and antiinfectives. A total of eight new vaccines and other antiinfective products received marketing approval last year.
Cervarix, GlaxoSmithKline`s bivalent vaccine, was licensed in October to protect against cancer caused by human papillomavirus (HPV) infection. The product joins Merck`s quadravalent product, Gardasil, as the only U.S.-licensed HPV vaccines. HPV vaccination is recommended for girls and young women before they are exposed to the sexually transmitted virus.
GlaxoSmithKline`s Haemophilus influenza type b (Hib) conjugate vaccine, Hiberix, was licensed in August. According to FDA, the agency expedited the approval of the vaccine to ease a shortage of Hib vaccine that began in late 2007. Hiberix is indicated for use as a booster in children 15 months through 4 years of age.
FDA in March licensed Ixiaro, from Intercell AG and Novartis, to protect against disease caused by Japanese encephalitis virus. The mosquito-borne organism is found in Asia and can infect travelers to areas where the virus is endemic. According to the Centers for Disease Control and Prevention, the Japanese encephalitis virus is the leading cause of viral encephalitis in Asia, causing 30,000–50,000 cases of the disease each year.
Novartis in late November added a second U.S.-licensed trivalent influenza virus vaccine to the company`s product line. Agriflu is the seventh trivalent seasonal influenza virus vaccine currently licensed for use in the United States.
In addition to the trivalent influenza vaccines, monovalent formulations from five manufacturers were cleared for use against the H1N1 influenza virus that emerged last spring. FDA treated the vaccines as strain changes to licensed products and not as new biological products.
Two antiinfective products were approved for the treatment of parasitic infections. Coartem artemether–lumefantrine combination tablets from Novartis were approved for the treatment of malaria. Ulesfia, a benzyl alcohol lotion from Sciele, were approved for the treatment of head lice infestation.
Theravance`s injectable telavancin product Vibativ, a synthetic vancomycin derivative, was approved in September for the treatment of complicated skin and skin-structure infections. Bausch & Lomb`s Besivance ophthalmic suspension, containing besifloxacin hydrochloride, was approved in May for the treatment of bacterial conjunctivitis.
Diseases related to inflammation. Gout sufferers have two newly approved oral remedies for the treatment of the painful condition: colchicine tablets, sold as Colcrys by Ar Holding, and febuxostat, or Uloric, from Takeda.
Febuxostat, a xanthine oxidase inhibitor, reduces serum uric acid levels in patients with gout, and colchicine is indicated for the treatment of gout flares. An additional indication in the labeling for colchicine is the treatment of familial Mediterranean fever, an inherited inflammatory disease that affects the abdomen, chest, or joints.
Three injectable monoclonal antibody products—canakinumab (Ilaris), from Novartis; golimumab (Simponi), from Centocor; and ustekinumab (Stelara), also from Centocor—were licensed for the treatment on inflammation-related conditions.
Golimumab, a tumor necrosis factor-alfa inhibitor, was licensed in April and is indicated for the treatment of moderate to severe rheumatoid arthritis, active psoriatic arthritis, or active ankylosing spondylitis.
Ustekinumab targets interleukin (IL)-12 and IL-23 and was licensed in September for the treatment of severe plaque psoriasis.
Canakinumab, an IL-1beta inhibitor, was licensed for the treatment of familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Both are rare inherited diseases related to a mutation in the gene that encodes cryopyrin.
Also approved for the treatment of inflammatory conditions was Extavia, an interferon beta-1b product from Novartis indicated for the treatment of relapsing forms of multiple sclerosis, and milnacipran hydrochloride, or Savella, a selective serotonin–norepinephrine reuptake inhibitor from Cypress. The product is indicated for the treatment of fibromyalgia.
Cardiovascular conditions. Six new prescription medications related to cardiovascular disease earned marketing approval last year.
Among these are two products with different mechanisms of action that were approved for the treatment of hereditary angioedema. Berinert is a human C1 esterase inhibitor made by CSL Behring. Ecallantide injection, or Kalbitor, is a plasma kallikrein inhibitor from Dyax.
Pitavastatin in August became the latest hydroxymethylglutaryl–coenzyme A inhibitor to win FDA approval for the treatment of dyslipidemia.
Prasugrel, Eli Lilly`s platelet activation and aggregation inhibitor, was approved in July to reduce the risk of heart attack and stroke in patients who are undergoing catheterization surgery to reopen an occluded coronary artery.
Dronedarone, a benzofuran derivative sold as Multaq by Sanofi, was approved in July to reduce the risk of cardiovascular-related hospitalization in patients with persistent atrial fibrillation or atrial flutter.
Tolvaptan, sold as Samsca by Otsuka, is a selective, competitive arginine vasopressin receptor-2 antagonist indicated for the treatment of patients with hypervolemic or euvolemic hyponatremia.
2009 Pharmaceutical Product Approvals
New molecular entities and new biologicals, 2009a
Abobotulinumtoxin A for injection (Dysport, Ipsen), for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain and for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age
Antithrombin, recombinant, for i.v. infusion (Atryn, GTC Biotherapeutics), for the prevention of perioperative and peripartum thromboembolic events in patients with hereditary antithrombin deficiency
Artemether–lumefantrine oral tablets (Coartem, Novartis), for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least 5 kg
Asenapine maleate sublingual tablets (Saphris, Organon), for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults
Benzyl alcohol lotion (Ulesfia, Sciele), for the treatment of head lice infestation
Bepotastine besilate ophthalmic solution (Bepreve, Ista), for the treatment of ocular itching associated with allergic conjunctivitis in patients age 2 years or older
Besifloxacin hydrochloride ophthalmic suspension (Besivance, Bausch & Lomb), for the treatment of bacterial conjunctivitis
C1 esterase inhibitor, human, for i.v. infusion (Berinert, CSL Behring), for the treatment of acute abdominal or facial attacks of hereditary angioedema in adults and adolescents
Canakinumab s.c injection (Ilaris, Novartis), for the treatment of familial cold autoinflammatory syndrome and Muckle-Wells syndrome in patients age 4 years or older
Colchicine oral tablets (Colcrys, AR Scientific), for the treatment of gout flares and familial Mediterranean fever
Dronedarone hydrochloride oral tablets (Multaq, Sanofi), for the maintenance of normal heartbeat in certain patients with a history of paroxysmal or persistent atrial fibrillation or atrial flutter
Ecallantide injection (Kalbitor, Dyax), for the treatment of acute attacks of hereditary angioedema in patients age 16 years or older
Everolimus oral tablets (Afinitor, Novartis), for the treatment of advanced renal cell carcinoma
Febuxostat oral tablets (Uloric, Takeda), for the reduction of elevated serum uric acid levels in patients with gout
Ferumoxytol injection (Feraheme, AMAG), for the treatment of iron deficiency anemia in adults with chronic kidney disease
Fibrinogen concentrate, human, for i.v. infusion (Riastap, CSL Behring), for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency
Golimumab injection (Simponi, Centocor), for the once-monthly treatment of adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, or active ankylosing spondylitis
Haemophilus b conjugate vaccine solution for i.m. injection (Hiberix, GlaxoSmithKline), for the prevention of invasive disease caused by Haemophilus influenzae type b in children 15 months through 4 years of age
Human papillomavirus bivalent vaccine, recombinant, suspension for i.m. injection (Cervarix, GlaxoSmithKline), to protect against cancers caused by infection with human papillomavirus types 16 and 18
Iloperidone oral tablets (Fanapt, Vanda), for the acute treatment of schizophrenia in adults
Immune globulin, i.v., human liquid (Gammaplex, Bio Products), for the treatment of patients with primary humoral immunodeficiency
Influenza virus vaccine, inactivated, suspension for i.m. injection (Agriflu, Novartis), for active immunization of adults 18 years of age or older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine
Interferon beta-1b for s.c. injection (Extavia, Novartis), for the treatment of relapsing forms of multiple sclerosis
Japanese encephalitis vaccine, inactivated, adsorbed suspension for i.m. injection (Ixiaro, Intercell), for the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age or older
Milnacipran hydrochloride oral tablets (Savella, Cypress), for the treatment of fibromyalgia
Ofatumumab for i.v. infusion (Arzerra, GlaxoSmithKline), for the treatment of chronic lymphocytic leukemia in patients whose cancer does not respond to other chemotherapy
Pancrelipase oral capsules (Creon, Solvay), for the treatment of pancreatic insufficiency in adults and children with exocrine pancreatic insufficiency resulting from cystic fibrosis or other conditions
Pazopanib hydrochloride oral tablets (Votrient, GlaxoSmithKline), for the treatment of advanced renal cell carcinoma
Pitavastatin calcium oral tablets (Livalo, Kowa), for the improvement of cholesterol levels in patients who have not been able to control their dyslipidemia through diet and exercise
Pralatrexate injection (Folotyn, Allos), for the treatment of peripheral T-cell lymphoma in patients whose disease has returned or not responded to previous therapy
Prasugrel hydrochloride oral tablets (Effient, Eli Lilly), to reduce the rate of myocardial infarction and stroke in patients with acute coronary syndrome who are undergoing a catheter-based procedure to reopen an occluded coronary artery
Romidepsin for injection (Istodax, Gloucester), for the treatment of cutaneous T-cell lymphoma in patients who have already received at least one systemic therapy for the disease
Saxagliptin hydrochloride oral tablets (Onglyza, Bristol-Myers Squibb), to help control blood glucose concentrations in patients with type 2 diabetes
Telavancin hydrochloride for injection (Vibativ, Theravance), for the treatment of complicated skin and skin-structure infections in adults
Tolvaptan oral tablets (Samsca, Otsuka), for the treatment of patients with hypervolemic or euvolemic hyponatremia
Ustekinumab for s.c. injection (Stelara, Centocor Ortho Biotech), for the treatment of severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy
Vigabatrin oral tablets and powder for oral solution (Sabril, Lundbeck), for the treatment of infantile spasms and as add-on therapy for the treatment of complex partial seizures in adults
aFrom information available on FDA`s Web site, January 2010.
