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Pharmacy Practice News • November 2014
FDA Watch
FDA Approves Trulicity To Treat Type 2 Diabetes
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he FDA has approved dulaglutide (Trulicity, Eli Lilly), a once-weekly subcutaneous injection to improve glycemic control in adults with type 2 diabetes. The medication is to be used with diet and exercise. Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and efficacy were evaluated in six clinical trials, in which 3,342 patients with type 2 diabetes received treatment. Patients taking dulaglutide saw an improvement in their glycemic control with reductions in hemoglobin A1c level, according to the FDA. Dulaglutide has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione and prandial insulin.
The medication is contraindicated for those e with type 1 diabetes or any diabetic patient with diabetic ketoacidosis or gastrointestinal issues. It should not be used as first-line therapy, according to the FDA. The label carries a boxed warning that thyroid C-cell tumors have been observed in rodent studies, but it is unknown whether dulaglutide causes human tumors. The tumorss were related to dose and treatment duration, according to a company press release. Dulaglutide should not be prescribed for patients with a personal or family history of medullary thyroid carcinoma (MTC) or who have multiple endocrine neoplasia syndrome type 2, which predisposes them to MTC. The FDA approved dulaglutide with a Risk
Evalu uation and Mitigation Strategy (REMS), whic ch consists of a communication plan to inform health care professionals about the serious risks associated with the medication. The FDA A is requiring several postmarketing studies to a assess ongoing safety. Trulicity comes in a single-dose pen and doess not require mixing, measuring or needle a attachment. Trulicity is administered once week kly, any time of day, and independent of meals, and should be injected subcutaneously in the abdomen, thigh or upper arm. The recomm mended starting dose is 0.75 mg, and can be in ncreased to 1.5 mg for patients who need additional blood sugar control. Lilly plans to make Trulicity 0.75 and 1.5 mg ssingle-dose pens available for adults in the United States later this year, according to U tthe company.
Relistor Approved for OIC in Noncancer Pain Patients
Obizur Approved For Bleeding Disorder
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The FDA has approved the antihemophilic factor (recombinant), porcine sequence, Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A. Obizur (Baxter) was given priority review and granted orphan drug status. Acquired hemophilia A (AHA) is caused by the development of antibodies directed against the body’s own factor VIII (FVIII), a protein important for blood clotting. As a result, patients with AHA experience excessive bleeding that can occur spontaneously or following an event, such as injury or surgery. Unlike hereditary hemophilia, AHA is not a genetic disorder and affects both males and females. The development of AHA has been associated with other medical conditions or health states, such as pregnancy, cancer or the use of certain medications. However, in about half of cases, no underlying cause can be found. Diagnosis of this condition can be difficult and the severity of the bleeding can make treatment challenging. “The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease,” said Karen Midthun, MD, the director of FDA’s Center for Biologics Evaluation and Research. Obizur is the first treatment approved for AHA that allows physicians to manage the drug by measuring factor VIII activity levels in addition to clinical assessments. Obizur contains a recombinant analog of porcine FVIII, which is used because it is sufficiently similar to human FVIII to be effective in blood clotting, but is less susceptible to inactivation by circulating human factor VIII antibodies. The safety and efficacy of Obizur was evaluated in a multicenter Phase II/III open-label clinical trial of 29 patients. One hundred percent of patients treated with Obizur showed a positive response, meaning an effective or partially effective response with bleeding stopped or reduced and clinical improvement at 24 hours after the initial infusion. Successful treatment of the initial bleeding episode was seen in 86% of patients. The investigators defined overall treatment success as the ability to discontinue or reduce the dose and/or dosing frequency of Obizur. The most common adverse reaction, observed in more than 5% of patients, was the development of inhibitors to porcine FVIII.
he FDA has expanded the indication for Relistor subcutaneous injection to include the treatment of opioid-induced constipation (OIC) in patients with chronic noncancer pain. Relistor (methylnaltrexone bromide, Salix and Progenics) is a peripherally acting μ-opioid receptor antagonist that works by blocking the constipating effects of opioids in the gastrointestinal tract without interfering with analgesic properties. It was previously approved in 2008 for treating OIC in patients with advanced illnesses in palliative care when response to laxative therapy was not sufficient. A Phase III, randomized, double-blind, placebocontrolled clinical trial in 312 patients examined the safety and efficacy of Relistor 12 mg. Eligible participants had a history of noncancer pain, were taking opioids for at least one month before the trial and had confirmed OIC defined as less than three spontaneous bowel movements (SBM) per week during the screening period. Patients were given either Relistor 12 mg or a placebo once a day for four weeks, followed by an eight-week period when they could take medications as needed. Researchers found that 58% of patients who took Relistor 12 mg daily reported three or more SBM per week during the four-week double-blind period, compared with 38% in the placebo group. They also found that 33% of the Relistor group had an SBM within four hours of the first dose; approximately half had an SBM before the second dose. Relistor was well tolerated, according to the researchers. Commonly reported side effects included abdominal pain, diarrhea, nausea and hyperhidrosis.
Nova StatStrip Glucose Hospital Meter System
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he FDA has approved a new indication for the Nova StatStrip Glucose Hospital Meter System (Nova Biomedical), extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by the FDA for use in these patients, according to the agency. The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results. Consequently, the agency cleared the test with a waiver under Clinical Laboratory Improvement Amendments (CLIA) that allows many members of the health care team to perform the test at the point of care. (Complex diagnostic tests, in contrast, need to be performed in a hospital or other laboratory, as per CLIA regulations.)
The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use in critically ill patients. Data supporting the clearance included a study of more than 1,650 patients who had a range of medical conditions that were treated in various care settings in the hospital (i.e, cardiac, emergency intensive care and surgical). In all patients tested, results showed agreement in blood glucose results compared with a laboratory glucose analyzer.