This is an archive page. The links are no longer being updated.
Date: January 14, 1997 FOR IMMEDIATE RELEASE Contact: Donald C. McLearn: 3014431130, Broadcast Media: 3018273434, Consumer Hotline: 8005324440
The recordsetting results achieved without sacrificing the agency's high review standards are a clear sign of the success of the Prescription Drug User Fee Act (PDUFA) fiveyear program, in which the agency uses fees paid by manufacturers to shorten its drug review and approval times.
The highlight of the year was the approval of 131 new drugs, a 60 percent increase over the 82 new drugs approved in 1995, in the median time of 15.4 months, 7 percent faster than the 16.5 months the year before. Fiftythree of these medications 89 percent more than the 28 such drugs in 1995 were new molecular entities (NMEs), products containing an active substance that had never before been approved for marketing in any form in the United States.
The NMEs were approved in the median approval time of 14.3 months, 10 percent faster than the 15.9 months in 1995.
Nine of the NMEs, including 3 HIV therapies and 2 cancer drugs, were approved in six months or less. Crixivan, a protease inhibitor for the treatment of HIV, was approved in the record time of 1.4 months. In addition to Crixivan, the NMEs included HIV drugs Norvir and Viramune, which received approval in 2.3 months and 3.9 months, respectively. The median development time for the NMEs from first commercial Investigational New Drug submission to New Drug Application approval was less than 9 years. Twelve of these drugs, including three protease inhibitors, were developed in less than six years.
New cancer drugs approved last year were notable for their effectiveness against a broad spectrum of cancers: Hycamtin is indicated for metastatic carcinoma of the ovary; Camptosar for colorectal cancer; Taxotere for advanced breast cancer; Gemzar for cancer of the pancreas; and Nilutamide for cancer of the prostate.
The NME category included also Accolate, the first of a new class of drugs for asthma; Aricept, the second treatment for Alzheimer's disease; and Copaxone, which is indicated for the treatment of relapsingremitting multiple sclerosis.
For biologics, the agency's firsttime approvals included one new vaccine and seven therapeutic products, including a plasma derivative. The 8 firsttime approvals were among 17 major biological approvals as compared with 12 such approvals the year before. The median approval time for these 17 products was 14.9 months, 15 percent faster than the 17.6 months in 1995.
Major biological products approved last year included Respigam, the first medication to protect infants against serious RSV respiratory syncytial virus disease; Avonex, the second interferon product for multiple sclerosis; and Verluma, a new diagnostic imaging agent that can determine the extent of small cell lung cancer in different parts of the body at one time.
Also of note was also the approval of five new HIV test kits, including the Amplicor HIV1 Monitor test, which predicts HIV disease progression by measuring virus levels in blood, and two home collection kits, which allow individuals to collect blood samples, send them to a testing laboratory, and obtain results by phone.
Major supplemental approvals of already marketed biological products included Activase, the first therapy shown to improve recovery from acute ischemic stroke, and Tripedia, an acellular pertussis vaccine to protect infants against whooping cough.