Research pipeline
From March/April 2006 Psoriasis Advance
This is a time of optimism for people with psoriasis and psoriatic arthritis. New treatments have come to the market at an unprecedented rate. And many of the drugs approved in the past several years go far beyond controlling symptoms—they're working to block psoriasis and psoriatic arthritis at their source, in the immune system.
New drugs are constantly being developed and
are making their way through the drug-approval
process. Pharmaceutical companies often chart
their drugs in development in what is known as
a "research pipeline" on their Web sites or annual
reports. The pipeline tracks the movement of drugs
from preliminary studies through the three phases
of clinical trials done in cooperation with the U.S.
Food and Drug Administration (FDA), which is
responsible for drug approvals.
The National Psoriasis Foundation compiles and
updates similar information from public sources in
our own drug research pipeline—a tool we use to
track the progress of psoriasis and psoriatic arthritis
treatments in development.
We believe the research pipeline is important because
it can offer patients hope and encouragement
that researchers are working to develop safer and
more effective treatments for psoriasis and psoriatic
arthritis. Knowing about drugs in development can
empower people to take an active role in managing
these diseases.
"There is a large amount of effort going into the
development of new treatments for psoriasis and
psoriatic arthritis," says Gerald G. Krueger, M.D.,
professor of dermatology at University of Utah
Health Sciences Center, and psoriasis clinical researcher.
"This makes for continued optimism for
patients and doctors alike."
Research Pipeline: A look at the drug approval process
How are drugs for psoriasis discovered?
Drugs can be discovered in many ways. Sometimes
drugs will be used for one disease, and as treatment
progresses, a doctor will notice another condition
is also improving. Cyclosporine, for example, was
originally approved as an anti-rejection drug for
people with organ transplants. At some point, doctors
noticed that a number of patients had their
psoriasis improve when using cyclosporine. The
U.S. Food and Drug Administration (FDA) approved
cyclosporine to treat psoriasis in 1997.
Basic science researchers (those who work in the
laboratory) are working to develop drugs for psoriasis
by trying to determine the mechanism, or
process, of the disease in the body. Psoriasis goes
through many steps, from its beginnings in the
genes to the appearance of psoriasis lesions on the
skin. When creating a new drug, researchers will
create compound(s) that interfere with those steps.
There are many places for a drug to interrupt the
disease process. Topical medications, for example,
treat psoriasis at the skin level, whereas biologics
make changes at the immune system level, aiming
to block the disease before it appears on the
skin. Newer drugs that are being created and tested
attempt to stop psoriasis earlier in the disease
process.
How does a psoriasis drug get approved by
the U.S. Food and Drug Administration?
To get FDA approval, new drugs for psoriasis must
go through a long, highly structured process. Before
a drug can be tested in humans, it must be
tested in extensive preclinical (laboratory) research.
This research can involve years of testing in animal
or human cells, and then in animals. After a drug
passes rigorous criteria, it can be tested in people.
Once approved for testing in humans, the drug
must go through a series of three phases of study.
After a company completes the third
phase, it can apply to the FDA for approval to begin
marketing the drug.
Many drugs are developed, but few make it all the
way to market. There is a 20 percent success rate
for new drugs that make it through early trials to
become new treatments.
How long does it take a drug to get approved
by the FDA?
Drug development may take 12 to 17 years from
discovery to final approval by the FDA.
- Preclinical development (testing on animal or
human cells and/or testing in animals) can take
three to four years.
- Researchers then submit an Investigative New
Drug (IND) application, which can take another
year for approval.
- When combined, phases I, II and III can take
six to eight years.
- When the results are favorable, the company will
file a New Drug Application (NDA). The NDA
contains results of all clinical studies, descriptions
of manufacturing processes, descriptions of packaging for the new drug, and a copy of
the proposed package insert which describes
how the medication will be used and any precautions.
The process of submitting the NDA,
and the time it takes for the FDA to review it
and potentially approve it, can take another two
to three years.
Why would a drug not make it to market or be
pulled off the market after it's approved?
Generally, drugs are not successful in trials because
they didn't work as expected or had dangerous
side effects. Companies spend years of effort and
millions of dollars to bring new treatments to the
market. When a drug is not successful, companies
will frequently stop developing it. Approved drugs
can be pulled off the market when there are rare,
unexpected side effects; when the drug is more
toxic than expected; when safer treatment options
are available; or when the drug is improperly used.
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