Amylin Pharmaceuticals Inc. withdrew its marketing application in Europe for the diabetes product Symlin after regulatory officials said additional information may be necessary for approval.
Symlin (pramlintide acetate) is an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas. San Diego-based Amylin has sought approval for Symlin in both the U.S. and Europe for Type I and insulin-dependent Type II diabetes patients.
The approval process in the U.S. has not been without a few setbacks, culminating with an approvable letter issued last fall requiring additional tests. (See BioWorld Today, Oct. 15, 2001.)
The situation in Europe is not clear at this point, Eric Shearin, Amylin's manager of investor relations, told BioWorld Today. "We just got an indication that they didn't have enough information or they weren't ready to make a decision. That left us with two options: We could push forward and hope they get comfortable with the application by the time they had to vote, or we could pull the application and talk to them and figure out what they need, and resubmit."
He said company officials are expected to meet with European decision-makers in the next few weeks.
When asked whether Amylin suspects that European officials have concerns similar to those raised by the FDA, Shearin said it is too early to speculate. "We don't believe it is the same problem, but unfortunately the format of the [European] meeting doesn't allow for a detailed discussion of what will be needed."
In its approvable letter, the FDA raised questions about severe hypoglycemia and nausea experienced by some Type I diabetes patients in the first four to six weeks of therapy, said Shearin, who also commented that this type of problem is not uncommon when diabetes patients are given a new therapy over insulin.
"Our approvable letter says we've already established efficacy, so our goal now is to show that we can initiate therapy by titrating Symlin, or starting with a lower dose and working up slowly," he said.
In July 2001, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-to-1 against using Symlin for Type I patients and 6-to-3 against use for Type II patients. However, in an 8-to-1 vote, the panel said the trials proved efficacy, but in another 8-to-1 vote, the panel said Symlin did not appear to be safe. (See BioWorld Today, July 27, 2001.)
Final approval is subject to satisfactory results from the dose-titration study and four small pharmacology studies already completed or under way, the company said.
Shearin said Amylin expects to submit an amendment to the new drug application by the end of the first quarter of 2003 and looks forward to a decision six months thereafter.
Amylin and Brunswick, N.J.-based Johnson & Johnson worked together in the development of Symlin before terminating the partnership in 1998. Johnson & Johnson spent $175 million on the deal before pulling out. The first sign of trouble occurred when a Phase III trial in Type II diabetes failed to show lower glucose on an intent-to-treat basis after 12 months. (See BioWorld Today, Aug. 9, 1997, and March 8, 1998.)
Amylin's stock (NASDAQ:AMLN) closed Thursday at $16.76, down less than a penny.