The U.S. Food and Drug Administration approved 132 new drugs and biologic products in 1997, the second highest number of approvals made in one year by the agency since initiation of the Prescription Drug User Fee Act of 1992.
Once again, the highlight of the year was a reduction in the median approval time for drugs and biologic products. The median approval time for 121 new drugs in 1997 was reduced by 6 percent to 14.4 months, compared with 15.4 months in 1996. Thirty-nine of these medications were new molecular entities (NMEs), products that had never been approved in any form in the United States. The median approval time for NMEs was 13.4 months, which was 6 percent faster than the 14.3-month approval time for NMEs in 1996. Since 1996, the FDA has reviewed and approved more than 90 NMEs.
New Molecular Entities
Four NMEs, including two antidiabetic agents, were approved in six months or less. Troglitazone (Rezulin) and repaglinide (Prandin) were approved for treatment of type 2 (non-insulin-dependent) diabetes. Nelfinavir (Viracept), a protease inhibitor for the treatment of human immunodeficiency virus (HIV) infection, was approved in 2.6 months. A selective estrogen receptor modulator, raloxifene (Evista), was approved for prevention of osteoporosis in postmenopausal women.
Two of the five new cancer drugs approved last year were indicated for treatment of advanced breast cancer: toremifene (Fareston) and letrozole (Femara). The remaining three agents were approved for a variety of indications. Sterile aerosol talc (Sclerosol) was approved for the prevention of recurrence of malignant pleural effusion, samarium Sm-153 lexidronam. (Quadramet) was approved for the treatment of pain associated with osteoblastic metastatic bone lesions, and dolasetron (Anzemet) was approved for the prevention of nausea and vomiting associated with chemotherapy and surgery.
The NME category also included fomepizole (Antizol), the first drug indicated as an antidote for ethylene glycol poisoning; clopidogrel (Plavix), for the reduction of atherosclerotic events; pramipexole (Mirapex) and ropinirole (Requip) for treatment of Parkinson’s disease, and carbon-14-urea breath test (PYtest), a new diagnostic breath test for the detection of Helicobacter pylori.
In addition to 39 NMEs, 11 new product and biologic license applications (PLAs and BLAs) were approved in a median time of 14.5 months (20 percent faster than the 18.1 months’ median time of the previous year). Ten of these major approvals were first-time approvals of products containing a substance or combination of substances never before approved for the U.S. market, compared with eight such approvals in the previous year. The agency’s first-time approvals included seven therapeutic products and three vaccines. (One of the vaccines is a bulk product that is used only in the manufacture of Infanrix.) The 12 months’ median time for first-time approvals in 1997 was 20 percent faster than the median time of 15.08 months required for such approvals in 1996.
Major biologic products approved last year included autologous cultured chondrocytes (Carticel), indicated for the repair of clinically significant, symptomatic cartilaginous defects caused by trauma; becaplermin (Regranex Gel 0.01 percent), for the treatment of diabetic neuropathic ulcers of the lower extremity, and interferon alfacon-1 (Infergan) for the treatment of chronic hepatitis C viral infection. The new biologic products are listed in Table 1.
TABLE 1 Significant New Biologic Products Approved in 1997
Product Use/indication
Therapeutics
Autologous cultured Repair of cartilaginous
chondrocytes. (Carticel)(*) defects of the femoral
condyle
Becaplermin (Regranex Gel 0.01 %)(*) Once-daily treatment of
diabetic ulcers
Coagulation factor IX recombinant Control and prevention of
(BeneFIX)(*)([dagger]) hemorrhagic episodes of
hemophilia B
Daclizumab (Zenapax)(*)([dagger]) Prevention of acute renal
allograft rejection
Interferon alfacon-1 (Infergan)(*) Treatment of chronic
hepatitis C
Oprelvekin (rhlL 11; Prevention of severe
Neumega)(*)([dagger]) thrombocytopenia
following chemotherapy
Rituximab (Rituxan)(*)([dagger]) Treatment of relapsed or
refractory low-grade or
follicular,
B-cell non-Hodgkin’s
lymphoma
Vaccine
Diphtheria and tetanus toxoids Immunization of infants and
and acellular pertussis (DTaP) children, 6 weeks to 7
adsorbed vaccine (Infanrix) years of
age, against diphtheria,
tetanus and pertussis
Rabies vaccine (RabAvert) Immunization of children and
adults against rabies