Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

The development time (from initiation of pivotal trials to approval) for drugs/biologics to treat life-threatening illnesses is currently averaging under five years, according to a recent FDA report on 30 drugs approved during this decade. The FDA report, entitled "A Research Profile of Thirty Recent Therapies for the Treatment of Life-Threatening and Severely Debilitating Illnesses," analyzes data on products that the agency feels would have qualified for expedited review under its recent regulations for treatments of life-threatening illnesses. The agency found that the average time from initiation of pivotal trials to NDA approval was 7.1 years for the 17 therapies approved between 1980 and 1985 and 4.7 years for the 13 therapies approved between 1986 and the first half of 1988. Because development time is calculated from the start of "the first clinical study that was pivotal in documenting the life-saving quality of the therapy," Phase I study time is typically excluded; another FDA study estimates the average time for a successful Phase I trial at seven months. The principal time-saving factor for the post-1985 approved products was timing of the NDA submissions. NDAs in the earlier group on average were submitted 0.9 years after the data cut-off date of the first pivotal study, while NDAs in the latter group were submitted an average of 0.7 years before the data cut-off date. FDA attributes the earlier submissions to more active involvement of the agency in drug development and increased cooperation with industry. "The statistical evidence of a 1.6 year acceleration in the submission of NDAs for recent VITs [vitally important therapies] is confirmation that [a] more active role for FDA is not only feasible, but very much a reality for the 13 VITs approved in the past three years," the report states. "The fact that most NDA submissions for VITs now occur before completion of research is a sign of the increased cooperation, trust and sense of urgency among sponsors, researchers and regulators in the development of vitally important therapies." FDA Commissioner Young also highlighted the role of early and close communications with industry in an Oct. 26 presentation of the study results to a jointly-sponsored FDA/American Medical Association symposium on expedited approvals. Noting the 4.7 year development time for recent therapies, Young predicted that review times for vitally important therapies will be reduced further if communications are improved. "I think you'll see this decrease further," Young said, pointing out the 18-month development of aerosolized pentamidine and the 22-month development of AZT. "This basically comes from a much closer interaction" between FDA, the sponsor and the agency, Young said. "It's going to be extremely important as we continue these trends that we have closer and closer communications with the patient population that we serve." Shorter pivotal studies and swifter FDA review also contributed to the quicker development of the more recent NDAs. Pivotal studies for the 13 post-1985 approved drugs were roughly one year shorter than the 17 earlier products (2.8 years versus 3.9 years), and a half year was shaved off FDA's review time (1.8 years versus 2.3 years). FDA identified the 30 VITs from a review of 191 new molecular entities and "biological equivalents" approved between Jan. 1, 1980 and June 30, 1988. The agency also looked at marketing applications for new indications for already approved drugs and biologicals. The 30 products deemed to qualify for expedited review status include 17 new molecular entities, six new biologicals, six new indications for already marketed drugs, and one new indication for a biological. * Cardiovascular drug products were among the fastest developed therapies, with an average approval time of 4.3 years after start of the first relevant trial. The seven cardiovascular drug products were developed almost three years quicker than the other two major groups: seven anticancer drugs were cleared 7.1 years after the beginning of pivotal studies; and five anti-infectives were approved 7.0 years after the start of trials. The other eleven drugs/biologics, which include replacement therapies, antidotes, antivirals, immunosuppressants, and muscle relaxants, were approved in an average of six years. The faster development of cardiovasculars was due primarily to shorter trials and earlier submission of NDAs, rather than faster FDA review. The agency reviewed the major product classes in roughly equivalent time periods: cardiovasculars were on average reviewed in 2.1 years, compared to 2.3 years for anticancer drugs, 1.9 years for anti-infectives, and 2.1 years for the other classes combined. Trial time, however, was only 2.6 years for cardiovasculars, compared to 4.6 years for anticancer therapies, 4.9 years for anti-infectives and 3.5 years for all other therapies. Over the course of the eight-and-a-half year approval period studied by FDA, eight VITs were approved in the first three-year span, nine the following three years, and 13 in the last two-and-a-half year period. All seven of the biological therapies were cleared during the 1986-1988 period. The largest growth in development of VITs has been in the anticancer area; only two anticancer products were approved in the first six year period, while five were approved in the latter two-and-a-half year period studied by FDA. Anti-infective therapies exhibited the opposite trend, with all five approvals occurring before 1986. Chart omitted.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts