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发帖数: 444 | 1 FDA approves Eli Lilly's Trulicity to treat type 2 diabetes.
For Immediate Release
September 18, 2014
Release
The U.S. Food and Drug Administration today approved Trulicity (dulaglutide)
, a once-weekly subcutaneous injection to improve glycemic control (blood
sugar levels), along with diet and exercise, in adults with type 2 diabetes.
Type 2 diabetes affects about 26 million people and accounts for more than
90 percent of diabetes cases diagnosed in the United States. Over time, high
blood sugar levels can increase the risk for serious complications,
including heart disease, blindness, and nerve and kidney damage.
"Type 2 diabetes is a serious chronic condition that causes blood glucose
levels to rise higher than normal,” said Mary Parks, M.D., deputy director
of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation
and Research. “Trulicity is a new treatment option, which can be used
alone or added to existing treatment regimens to control blood sugar levels
in the overall management of type 2 diabetes.”
Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone
that helps normalize blood sugar levels. The drug’s safety and
effectiveness were evaluated in six clinical trials in which 3,342 patients
with type 2 diabetes received Trulicity. Patients receiving Trulicity had an
improvement in their blood sugar control as observed with reductions in
HbA1c level (hemoglobin A1c is a measure of blood sugar control).
Trulicity has been studied as a stand-alone therapy and in combination with
other type 2 diabetes therapies, including metformin, sulfonylurea,
thiazolidinedione, and prandial insulin. Trulicity should not be used to
treat people with type 1 diabetes; those who have increased ketones in their
blood or urine (diabetic ketoacidosis); those with severe stomach or
intestinal problems; or as first-line therapy for patients who cannot be
managed with diet and exercise.
Trulicity has a boxed warning that tumors of the thyroid gland (thyroid C-
cell tumors) have been observed in rodent studies with Trulicity but that it
is unknown whether Trulicity causes thyroid C-cell tumors, including a type
of thyroid cancer called medullary thyroid carcinoma (MTC), in humans.
Trulicity should not be used in patients with a personal or family history
of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (a
disease in which patients have tumors in more than one gland in their body,
which predisposes them to MTC).
The FDA is requiring the following post-marketing studies for Trulicity:
a clinical trial to evaluate dosing, efficacy, and safety in pediatric
patients;
a study to assess potential effects on sexual maturation, reproduction, and
CNS development and function in immature rats;
a medullary thyroid carcinoma (MTC) case registry of at least 15 years
duration to identify any increase in MTC incidence related to Trulicity;
a clinical trial comparing Trulicity with insulin glargine on glycemic
control in patients with type 2 diabetes and moderate or severe renal
impairment; and
a cardiovascular outcomes trial to evaluate the cardiovascular risk of
Trulicity in patients with high baseline risk of cardiovascular disease.
The FDA approved Trulicity with a Risk Evaluation and Mitigation Strategy (
REMS), which consists of a communication plan to inform health care
professionals about the serious risks associated with Trulicity.
In clinical trials, the most common side effects observed in patients
treated with Trulicity were nausea, diarrhea, vomiting, abdominal pain, and
decreased appetite.
Trulicity is manufactured by Indianapolis-based Eli Lilly and Company.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible
for the safety and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products. | s**********8
发帖数: 25265 | 2 不知道sales会怎么样.
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【在 z*****n 的大作中提到】
: FDA approves Eli Lilly's Trulicity to treat type 2 diabetes.
: For Immediate Release
: September 18, 2014
: Release
: The U.S. Food and Drug Administration today approved Trulicity (dulaglutide)
: , a once-weekly subcutaneous injection to improve glycemic control (blood
: sugar levels), along with diet and exercise, in adults with type 2 diabetes.
: Type 2 diabetes affects about 26 million people and accounts for more than
: 90 percent of diabetes cases diagnosed in the United States. Over time, high
: blood sugar levels can increase the risk for serious complications,
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