Amylin’s Symlin Rejected by FDA
More details sought from FDA on Amylin’s
new diabetes treatment.
Amylin was surprised by the FDA’s decision
for more information. Amylin believes it already
has data that would "contribute to the
discussion" of the FDA's latest concerns,
said Ginger Graham, the company's chief
executive. Those data come from two additional
ongoing studies the company has conducted since
submitting its application in June, Graham said,
so the FDA has not seen it.
More importantly this should not effect the
submission next year to the FDA of the
blockbuster drug exenatide which is the long
acting form. The information on exenatide had
been solid with few adverse events reported
during the trials.
Amylin Pharmaceuticals, which had been
awaiting word on the approval of its diabetes
drug Symlin, received a setback last Thursday
when U.S. regulators said they need more
information before allowing it on the market.
It is the second time the Food and Drug
Administration has tossed Symlin's drug
application back to the company in the form of
what is called an approvable letter, which
spells out additional requirements for approval.
San Diego-based Amylin answered the first
approvable letter by conducting more studies and
submitting a new application in June.
The FDA now has requested additional clinical
data to identify patients and dosing levels for
which the drug's benefits counterbalance the
risk of hypoglycemia or for which there are no
increased risks. Incidents of hypoglycemia, or a
lower-than-normal amount of blood sugar, are
usually caused by excess insulin.
Amylin believes it already has data that
would "contribute to the discussion"
of the FDA's latest concerns, said Ginger
Graham, the company's chief executive. Those
data come from two additional ongoing studies
the company has conducted since submitting its
application in June, Graham said, so the FDA has
not seen it.
"We have already initiated contact (with
the FDA) to schedule that discussion as quickly
as we can," Graham said.
Tthe FDA's slow action on the approval could
be a result of a debacle in 2000, when the FDA
pulled Warner-Lambert's diabetes drug Rezulin
off the market because of patient deaths. The
issue with that drug was liver toxicity, not
hypoglycemia.
McCamant said Symlin is not a monster product
for Amylin, with an anticipated market of about
$100 million. Analysts believe the company's
second drug, Exenatide, has a bigger market. The
company recently announced the successful
completion of three final-stage clinical trials
on that drug.
It has been a long and bumpy road for Amylin
to get its first drug approved.
In the summer of 2001, it appeared the drug
was ready for an obituary after an FDA advisory
committee recommended the agency reject the drug
because of issues with hypoglycemia. Among some
patients in clinical trials, there were episodes
of dangerously low blood-sugar levels,
particularly in the early stages of the therapy.
Also, a federal medical reviewer had issued a
harsh report questioning the efficacy of Symlin
and the way Amylin kept its medical records
during clinical trials.
But in October 2001, the FDA issued the first
approvable letter, which said Symlin could still
be approved pending additional clinical testing.
Graham said the company addressed the agency's
concerns in more recent studies.
The regulators' questions around the
appropriate administration of Symlin are a
"continued evolution" of the
discussion about hypoglycemia, Graham said.
"I do think it is very important for us to
stay focused on patient use. It is very
important for the patient and family to know how
to administer Symlin in conjunction with
insulin."
UPDATE: On Friday Amylin Pharmaceuticals Inc.
announced that the U.S. Securities and Exchange
Commission is conducting an informal inquiry in
connection with recent communications about its
experimental diabetes drug Symlin.
Start
your own 10,000 step program.