Eli Lilly and Company Announces Availability of Trulicity in U.S. Pharmacies
Nov 10 14
The newest GLP-1 receptor agonist treatment option to help improve glycemic control type 2 diabetes in adults is now available in U.S. pharmacies. Eli Lilly and Company's Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist designed with patients in mind. It comes in a single-dose pen and does not require the patient to mix, measure, or handle the needle. Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease. Trulicity has a Boxed Warning about potential risk of thyroid c-cell tumors including medullary thyroid carcinoma. It is contraindicated in patients with a personal history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of its product components. The U.S. Food and Drug Administration approved Trulicity on September 18, 2014 based on results from a number of studies of Trulicity used alone or in combination with commonly prescribed diabetes medications, including metformin, pioglitazone, glimepiride, and insulin lispro. It is now available to patients in 0.75 mg and 1.5 mg doses, delivered in the single-dose Trulicity pen. In a separate usability study, most patients agreed the Trulicity pen was easy to use. To help make the cost of therapy more manageable, the Trulicity Savings Card can reduce out-of-pocket costs to $25 for each prescription of Trulicity for a maximum of two years. This is available for commercially insured patients only. Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease. Important Safety Information for Trulicity. In male and female rats, dulaglutide causes dose-related and treatment duration dependent increase in the incidence of thyroid C-cell tumors after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans as human relevance could not be determined from clinical or nonclinical studies. Trulicity is contraindicated in patients with a personal or family history of
MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors. Trulicity is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components. Risk of Thyroid C-cell Tumors: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors. Patients with elevated serum calcitonin and patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapy. Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity Reactions: Systemic reactions were observed in clinical trials in patients receiving Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 RAs there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. The most common adverse reactions reported in >=5% of Trulicity-treated in placebo-controlled trials were nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia and fatigue. Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefit outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.
Eli Lilly and Company Announces U.S. Food and Drug Administration Approves CYRAMZA
Nov 5 14
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA(R) (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. CYRAMZA now has two FDA approvals for these patients. This FDA approval of CYRAMZA represents another milestone for people battling this devastating and difficult-to-treat disease. This FDA approval for CYRAMZA is based on the Phase III RAINBOW trial, which compared CYRAMZA plus paclitaxel to placebo plus paclitaxel. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate. The labeling for CYRAMZA contains a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. CYRAMZA should be permanently discontinued in patients who experience severe bleeding.
Boehringer and Eli Lilly Revise Operational Structure of Diabetes Alliance
Nov 3 14
Boehringer Ingelheim and Eli Lilly and Company have announced that they are revising the operational and financial structure of their diabetes alliance in certain countries. Under the revised agreement, 17 countries representing more than 90% of the alliance's anticipated market opportunity will continue their co-promotion work. In all other countries, the companies will exclusively commercialize the respective molecules they brought to the alliance. The changes will be implemented starting January 1, 2015. The scope of the alliance will remain unchanged in the following 17 countries: US, Germany, Italy, Spain, France, UK, Republic of Ireland, Portugal, Canada, Japan, China, Australia, New Zealand, South Korea, Taiwan, Brazil, and Mexico. Under a revised agreement, Boehringer Ingelheim and Lilly will exclusively commercialize the respective molecules they brought to the alliance in all other countries under revised financial terms that will include an upfront payment and ongoing payments paid to Lilly in lieu of commission payments in those markets.