Biotech Drug Approvals Top 90 With Hundreds More In Late-Stage Clinical Trials
That brings the number of biotech drugs and vaccines on themarket to 92. Total FDA biotech approvals from 1982 through 1999 reach 143 when adding clearances for new indications of existing medicines. The vast majority of product approvals for the biotech industry, which is only a quarter century old, came in the second half of the 1990s. These medicines benefit hundreds of millions of people worldwide with life-threatening illnesses, such as heart disease, cancer, Alzheimer's and AIDS.
"Our industry and its science have matured to the point that the number of life-saving drugs on the market and in late-stage clinical trials is skyrocketing," observed Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO). "Over the past five years approvals were double that of the previous 13 years combined. Some drugs represent the first effective treatments ever for our most intractable and debilitating diseases.
"Many biotech medicines, for example, target age-relateddiseases, a fact that should not be overlooked in the current discussions by Congress on Medicare reform," Feldbaum said. "Any legislative measures to expand access to drugs for Medicare beneficiaries must recognize that support for a healthy biotechnology industry is essential for making sure new therapies and cures get to patients.
more"With more than 350 biotechnology medicines already inlate-stage clinical trials for heart ailments, cancer, neurological diseases and infections, continued biotechnology innovation is the key not only for improving our health, but also for lowering our health care costs."
Among the approvals in 1999 were medicines for ovarian cancer,rheumatoid arthritis, hemophilia, influenza, and hepatitis C plus a first-of-its kind sustained-release form of growth hormone.
In recognition of the many advancements made by the biotechnology industry in health care, agriculture, manufacturing and environmental management, the U.S. Senate has declared January 2000 National Biotechnology Month.
BIO represents more than 860 biotechnology companies,academic institutions and state biotechnology centers in 46 states and more than 26 nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.
Product | Company | Application (use) | ApprovalDate |
Chiron RIBA HCV 3.0 Strip Immunoblot Assay |
Chiron/Johnson & Johnson | detection of antibodies to hepatitis C in human serum or plasma. | Feb. 1999 |
Depocyt | Depotech(SkyePharma)/ Chiron | treatment of lymphomatous meningitis | April 1999 |
Doxil (liposomal formulation of doxorubicin hydrochloride) | Alza | second-line therapy for Kaposi's sarcoma in AIDS patients (liposomal drug delivery system metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens | Nov. 1995 June 1999 |
Enbrel (etanercept) | Immunex | reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs; treatment of polyarticular course juvenile rheumatoid arthritis | Nov. 1998 May 1999 |
Epogen (epoetin alfa) | Amgen | treatment of anemia associated with chronic renal failure and anemia in Retrovir-treated HIV-infected patients; pediatric use | June 1989 July 1999 |
Hextend (hetastarch) | BioTime | plasma volume expander for treatment of hypovolemia during surgery | March 1999 |
Humate-P (antihemophilic factor/von Willebrand factor complex - human) | Centeon Pharma | treatment and prevention of bleeding episodes in hemophilia A adult patients; spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease in adult and pediatric patients, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate | April 1999 |
Infergen (interferon alfacon-1) |
Amgen | treatment of hepatitis C | Oct. 1997 Dec. 1999 |
Integrelin (eptifibatide for injection) | COR Therapeutics /Schering-Plough | treatment of patients with acute coronary syndrome and angioplasty; including patients who are to be managed medically and those undergoing percutaneous coronary intervention | May 1998 Sept. 1999 |
Luxiq | Connetics | relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp | Feb. 1999 |
Nabi-HB (hepatitis B immune globulin - human |
Nabi | treatment of acute exposure to HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure of infants to persons with acute hepatitis B | March 1999 |
NovoSeven (coagulation factor VIIa) | Novo Nordisk | treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX | March 1999 |
Nutropin/ Nutropin AQ (somatropin rDNA) |
Genentech | treatment of growth hormone deficiency in children; growth hormone deficiency in adults; growth failure associated with chronic renal insufficiency prior to kidney transplantation; short stature associated with Turner Syndrome; to improve spine bone mineral density observed in childhood onset adult growth hormone deficient patients and to increase serum alkaline phosphatase | Nov. 1993 Jan. 1994 Jan. 1996 Dec. 1996 Dec. 1999 |
Nutropin Depot (somatropin for injectable suspension) |
Genentech/Alkermes | long-acting dosage form of recombinant growth hormone (one or two doses a month) for pediatric growth hormone deficiency | Dec. 1999 |
Ontak | Ligand Pharmaceuticals | treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the Interleukin-2 receptor | Feb. 1999 |
Panretin (alitretinoin) | Ligand Pharmaceuticals | the topical treatment of cutaneous lesions of patients with AIDS-related Kaposi's sarcoma | Feb. 1999 |
Remicade (infliximab) | Centocor | short-term management of moderately to severely active Crohn's disease including those patients with fistula; treatment of patients with rheumatoid arthritis who have had inadequate response to methotrexate alone | Aug. 1998 Nov. 1999 |
Roche Amplicor HIV-1 RNA Test | Roche Molecular Systems | in vitro nucleic acid amplification test used for patient monitoring and as an aid in management of patients on anti-viral therapy for HIV disease | March 1999 |
Tamiflu (oseltamivir phosphate) |
Hoffmann-La Roche /Gilead Sciences |
treatment of most common strains of influenza (A&B) | Oct. 1999 |
Targetin (bexarotene) | Ligand Pharmaceuticals | treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy | Dec. 1999 |
Ultra-sensitive Amplicor HIV-1 Monitor test | Roche Molecular Systems | quantitative assay for HIV-1 RNA used to assess a patient's prognosis by measuring changes in plasma HIV-RNA levels during the course of antiviral treatment | March 1999 |
Wellferon (interferon alfa-n1, lymphoblastoid) | Glaxo Wellcome | treatment of chronic hepatitis C in patients 18 years of age or older without decompensated liver disease | March 1999 |
The medicines and vaccines included on this list are produced and/or developed by companies involved in recombinant DNA research or other biotechnology applications.