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.
Source: Diabetes In Control Dot Com.
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