|GSK receives FDA approval of an additional Promacta®; Jardiance Tablets For Adult Type 2 Diabetes available In U.S. Pharmacies|
|By Staff and Wire Reports|
|Tuesday, 26 August 2014 19:25|
SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets. 2 Eltrombopag, an oral thrombopoietin (TPO) receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.
"FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options," said Dr. Paolo Paoletti, President of Oncology, GSK. "Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage – red blood cells, platelets, or white blood cells – patients now have a treatment option where one didn't previously exist."
Promacta gained Breakthrough Therapy designation status from the FDA in January 2014 and Priority Review in April 2014. Today's approval by the FDA is based on results from an investigator-sponsored Phase II study (09-H-0154) conducted by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). The study demonstrated a haematologic response in SAA patients treated with eltrombopag who had an insufficient response to IST:1
-- Forty per cent (95% CI, 25, 56) of patients (N=17) experienced a haematologic response in at least one lineage – platelets, red blood cells (RBC), or white blood cells (ANC) – after Week 12.1
-- In the extension phase, eight patients achieved a multi-lineage response; four of these patients subsequently tapered off treatment and maintained the response (median follow up 8.1 months, range 7.2-10.6 months).
-- Ninety-one per cent of patients were platelet transfusion-dependent at baseline; the platelet transfusion-free period in responders ranged from eight to 1,096 days (median 200 days).
-- Eighty-six per cent of patients were RBC-transfusion dependent at baseline; the RBC transfusion-free period in responders ranged from 15 to 1,082 days (median 208 days).1
The most common adverse reactions (>/=20%) in the single-arm, open-label trial, in 43 patients with SAA who received Promacta were: nausea (33%), fatigue (28%), cough (23%), diarrhoea (21%), and headache (21%). In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Eight patients had a new cytogenetic abnormality reported, including five patients who had complex changes in chromosome 7. If new cytogenetic abnormalities are observed, discontinuation of Promacta should be considered.
Jardiance® (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers, according to Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY). The U.S. Food and Drug Administration (FDA) approved JARDIANCE on August 1, 2014 as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
"As a testament to the joint commitment by Boehringer Ingelheim and Lilly to improve care for people with diabetes, our alliance is proud to make JARDIANCE available so quickly following its approval by the FDA," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe JARDIANCE is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels."
JARDIANCE, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor. JARDIANCE works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels in adults with type 2 diabetes who have elevated blood glucose levels.
Patients should not take JARDIANCE if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in JARDIANCE. JARDIANCE can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.
The JARDIANCE Simple Savings co-pay support program is available online and in many doctors' offices for patients who qualify. For terms and conditions and any questions regarding eligibility or benefits, visit JARDIANCEsavings.com or call 1-866-279-8990.
The FDA approval of JARDIANCE was based on results from a large clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although JARDIANCE is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.
The most common adverse reactions associated with JARDIANCE were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of JARDIANCE and sulfonylurea or insulin.
To learn more about JARDIANCE and for full prescribing information visit: www.JARDIANCE.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
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