BETHESDA, MD 02 February 2009—FDA in 2008 approved the marketing of an assortment of 34 unique new molecular entities, vaccines, imaging agents, and blood products—5 more than the previous year`s total. A brief synopsis of several product approvals is provided below.
Injections for infections. In the category of infectious disease prevention and treatment, three new preventive childhood vaccines but just one antiinfective drug earned FDA approval last year.
The year`s first vaccine approval, in April, was for Rotarix, GlaxoSmithKline`s new oral vaccine that protects young children against infection with four rotavirus strains. In June, the company`s injectable vaccine Kinrix was licensed to protect children against diphtheria, pertussis, tetanus, and polio. Pentacel, a Sanofi Pasteur vaccine that protects against polio, invasive Haemophilus influenzae type b disease, diphtheria, tetanus, and pertussis was also licensed in June.
FDA in January approved the marketing of Tibotec Therapeutics` Intelence, or etravirine, an orally administered nonnucleoside reverse transcriptase inhibitor indicated for the treatment of HIV infection.
In the blood. Perhaps the largest broad category of FDA approvals for 2008 was blood- and clotting-related products, which accounted for six agency approvals or licensing actions.
FDA in January approved the marketing of Recothrom, a recombinant, plasma-free thrombin product by ZymoGenetics that helps control bleeding from capillaries and small veins during surgery. Recothrom was the first new product approved last year by FDA.
Artiss, a fibrinogen- and thrombin-containing sealant marketed by Baxter Healthcare, was approved in March for use in skin-grafting procedures.
The agency approved three new products for patients with bleeding disorders. Wyeth Pharmaceuticals` Xyntha, a recombinant antihemophilic factor that contains no plasma or albumin, was licensed in February for the prevention and control of bleeding episodes in people with hemophilia A.
Romiplostim, an injectable platelet-stimulating drug marketed by Amgen as Nplate, was approved in August as a second-line treatment patients with chronic immune thrombocytopenic purpura (ITP), a rare clotting disorder. Eltrombopag, an orally administered platelet-stimulating drug marketed by GlaxoSmithKline as Promacta, was approved in November for the treatment of ITP. Both products are available through restricted-distribution programs.
FDA in December approved plerixafor, a Genzyme drug that helps to stimulate the production of circulating hematopoeitic stem cells. Marketed as Mozobil, the product is indicated for use in patients with non-Hodgkin`s lymphoma or multiple myeloma whose hematopoeitic stem cells will be collected for autologous transplantation.
Cancer therapy. Two cancer treatments and one cancer chemotherapy antidote were approved in 2008. Cephalon`s bendamustine hydrochloride product, Treanda, was approved in March, and degarelix, by Ferring Pharmaceuticals, was approved in December; at press time, the Ferring product did not have a brand name.
Treanda, an alkylating agent, is indicated for the treatment of chronic lymphocytic leukemia. Degarelix is a gonadotropin-releasing hormone-receptor antagonist used for the treatment of prostate cancer.
Levoleucovorin, a folate analogue sold as Fusilev by Spectrum Pharmaceuticals, was approved in March for use as rescue therapy in patients with osteosarcoma treated with high-dose methotrexate and for reducing the toxic effects of inadvertent overdosage with methotrexate or other folic acid antagonists.
Get the picture. Four products for use in imaging procedures earned FDA approval in 2008. Regadenoson, an adenosine A2A-receptor agonist sold as Lexiscan by Astellas Pharma, was approved as a pharmacologic stress agent in patients undergoing radionuclide myocardial perfusion imaging. The product is indicated for use in patients who are unable to exercise adequately for the imaging procedure.
AdreView iobenguane I 123 injection, from GE Healthcare, was approved in September for use in gamma-scintigraphy to detect primary or metastatic pheochromocytoma and neuroblastoma in children and adults. According to the company, AdreView subjects patients to lower doses of radiation than other agents used to detect these tumors.
Two gadolinium-based contrast agents—gadofosveset trisodium, or Vasovist, by Epix Pharmaceuticals, and gadoxetate disodium, or Eovist, by Bayer HealthCare—also earned FDA approval last year. Vasovist is indicated for use in magnetic resonance angiography in patients with aortoiliac occlusive disease, and Eovist is indicated for use in magnetic resonance imaging of the liver.
A gut feeling. Three new products related to bowel function were approved last year. Certolizumab pegol, a pegylated tumor necrosis factor-alpha blocker sold as Cimzia by UCB, received FDA clearance in April for use as a second-line therapy in adults with moderate to severe Crohn`s disease. About 500,000 Americans suffer from the disease, according to the Crohn`s and Colitis Foundation of America.
Also approved in April was Wyeth`s methylnaltrexone bromide product, Relistor, an injectable drug indicated for the treatment of opioid-induced constipation in seriously ill adults receiving palliative care.
FDA in May approved Entereg, an alvimopan product from Adolor and GlaxoSmithKline indicated for the prevention of postoperative ileus in patients undergoing bowel resection surgery. A risk-management program governs the use of the product, which is available only for use in specially designated hospitals.
2008 Pharmaceutical Product Approvals
New molecular entities and new biologicals, 2008a
Alvimopan oral capsules (Entereg, Adolor), for the restoration of normal bowel function in hospitalized adults who have undergone partial large or small bowel resection surgery
Antihemophilic factor, recombinant, for i.v. use (Xyntha, Wyeth Pharmaceuticals), for surgical prophylaxis and to prevent and control bleeding in patients with hemophilia A
Bendamustine hydrochloride for injection (Treanda, Cephalon), for the treatment of chronic lymphocytic leukemia
C1 esterase inhibitor vaccine (Cinryze, Lev Pharmaceuticals), for routine prophylaxis against angioedema attacks in patients with hereditary angioedema
Certolizumab pegol for injection (Cimzia, UCB), for reducing the signs and symptoms of moderate to severe Crohn`s disease in adults
Clevidipine butyrate injectable emulsion (Cleviprex, Medicines Company), for lowering blood pressure when oral therapy is not feasible or not desirable
Degarelix for injection (Degarelix, Ferring Pharmaceuticals), for the treatment of advanced prostate cancer
Desvenlafaxine succinate oral tablets (Pristiq, Wyeth Pharmaceuticals), for the treatment of major depressive disorder
Difluprednate ophthalmic emulsion (Durezol, Sirion Therapeutics), for the treatment of inflammation and pain associated with ocular surgery
Diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (Kinrix, GlaxoSmithKline), for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children four to six years of age previously vaccinated against these agents using certain other GlaxoSmithKline vaccines
Diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine (Pentacel, Sanofi Pasteur), for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children six weeks through four years of age
Eltrombopag oral tablets (Promacta, GlaxoSmithKline), for the treatment of thrombocytopenia in patients with chronic immunethrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Estrogens, conjugated synthetic A, vaginal cream (Synthetic Conjugated Estrogens, A Vaginal Cream, Barr), for the treatment of moderate to severe vaginal dryness and pain with intercourse due to menopause
Etravirine oral tablets (Intelence, Tibotec Therapeutics), for the treatment of HIV-1 infection in treatment-experienced adults
Fenofibric acid oral capsules (TriLipix, Abbott), for the improvement of serum triglyceride and cholesterol levels
Fesoterodine fumarate oral tablets (Toviaz, Pfizer), for the treatment of overactive bladder
Fibrin sealant, human, topical (Artiss, Baxter Healthcare), for use as an adhesive to help attach autologous skin grafts
Fospropofol disodium injection (Lusedra, Eisai), for monitored anesthesia care sedation in adults undergoing diagnostic or therapeutic procedures
Gadofosveset trisodium injection (Vasovist, Epix), for use as a contrast agent in adults undergoing magnetic resonance angiography to evaluate aortoiliac occlusive disease
Gadoxetate disodium injection (Eovist, Bayer HealthCare), for use during magnetic resonance imaging of the liver in adults
Iobenguane sulfate I 123 injection (AdreView, GE Healthcare), for use as a diagnostic radiopharmaceutical agent for gamma-scintigraphy to detect primary or metastatic pheochromocytoma or neuroblastoma
Lacosamide oral tablets and injection (Vimpat, UCB), for the adjunctive treatment of partial-onset seizures in patients age ≥17 years
Levoleucovorin for injection (Fusilev, Spectrum), for use as a rescue agent in patients with osteosarcoma treated with high-dose methotrexate and for use as a countermeasure after inadvertent overdosage of folic acid antagonists
Methylnaltrexone bromide subcutaneous injection (Relistor, Wyeth), for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient
Plerixafor injection (Mozobil, Genzyme), to increase the number of circulating hematopoietic stem cells in patients with non-Hodgkin`s lymphoma or multiple myeloma who will undergo autologous hematopoietic stem-cell transplantation
Regadenoson injection (Lexiscan, Astellas Pharma), for use as a pharmacologic stress agent for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress
Rilonacept injection (Arcalyst, Regeneron Pharmaceuticals), for the treatment of cryopyrin-associated periodic syndromes in patients 12 years of age or older
Romiplostim for injection (Nplate, Amgen), for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Rotavirus vaccine, live, oral (Rotarix, GkaxoSmithKline), for the prevention of rotavirus gastroenteritis caused by G1, G3, G4, and G9 types in infants and children when administered to infants 6–24 weeks of age
Rufinamide oral tablets (Banzel, Esai), for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children four years or older and adults
Silodosin oral capsules (Rapaflo, Watson Pharma), for the treatment of signs and symptoms of benign prostatic hyperplasia
Tapentadol hydrochloride oral tablets (Tapentadol, Johnson & Johnson Pharmaceutical Research), for the relief of moderate to severe acute pain in adults
Tetrabenazine oral tablets (Xenazine, Cambridge Laboratories), for the treatment of chorea associated with Huntington`s disease
Thrombin, recombinant, topical (Recothrom, ZymoGenetics), as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical
aFrom information available on FDA`s Web site, January 2009.
