Symlin Passes Test for Glucose Control with
FDA Gets Closer to Market
The test showed that people with Type 1, or
childhood-onset diabetes, who take insulin daily
were better able to control their blood glucose
when they also took Symlin.
Amylin Pharmaceuticals Inc. yesterday said a
recently completed clinical test showed its diabetes
drug Symlin met federal regulators' expectations
for glucose control.
The trial showed other benefits as well. People
who took it were able to take less insulin, and
they lost weight. Typically people taking only
insulin gain weight.
The Food and Drug Administration conditionally
approved Symlin two years ago, pending more testing.
Amylin plans to submit the results of these additional
tests to the agency, which then has six months
to review the data.
The La Jolla-based biotech hopes to have the
drug approved by the end of the year, said Joann
Data, Amylin's senior vice president of regulatory
affairs and quality assurance.
The company could finally be reaching the end
of a bumpy 16-year journey to get its first drug
approved.
"This isn't Amylin's blockbuster drug,
the next one in its pipeline is," said John
McCamant, editor of the Medical Technology Stock
Letter in Berkeley. He was referring to exenatide,
another diabetes drug now in critical Phase III
trials. "This shows Amylin's ability to deal
with a messed-up FDA and do what they have to
do. It bodes well for them, bringing their next
drug through the pipeline."
More than four years ago, Amylin experienced
its first big setback in bringing Symlin through
the pipeline when Johnson & Johnson suddenly
withdrew from an agreement to co-promote the drug.
Amylin nearly went out of business and had to
cut its work force from 300 to 37 in less than
a year.
Then, about two years ago, the company was hit
with a double whammy. First, Dr. Robert Misbin,
a federal medical reviewer, called the effectiveness
of Symlin "trivial" and cited safety
concerns about the drug in a blistering report.
One day later, the FDA's Endocrinologic and
Metabolic Drugs Advisory Committee, also citing
safety concerns, said Symlin should be turned
down for approval. Some patients in tests developed
hypoglycemia, a severe drop in blood-sugar levels.
The FDA chose to ignore the committee and gave
Symlin conditional approval. But the agency required
five more tests for safety and efficacy, Amylin's
Joann Data said. Included in those was this most
recent test to see whether incidence of hypoglycemia
could be controlled.
In its original trials, Amylin was not allowed
to alter the amount of insulin given to the people
being tested, Data said. It is insulin that causes
hypoglycemia, or extremely low blood sugar.
In this most recent study, the dosage of Symlin
was gradually increased and the incidence of hypoglycemia
was reduced, Data said. Analysts project there's
a $500 million market for Symlin.
About 4.5 million Americans have Type 1 diabetes
and use insulin, said Eric Shearin, Amylin's manager
of investor relations. There are also 4.5 million
people in Europe who would be potential candidates
for Symlin, Shearin said.
"It's a niche product. It's not going to
replace any drug. But there are a significant
amount of people who use insulin, and they are
chronic. If they find success with Symlin, they're
going to keep using it," McCamant said.
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FACT:
25% of Patients with Diabetes Fail to Experience
Warning Signs of Myocardial Ischemia
Patients with type 2 diabetes appear no less sensitive
to myocardial ischemia than are comparable subjects
without diabetes, 25% of both, fail to experience
the warning signs, researchers report in the April
15th issue of the American Journal of Cardiology.
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