- New Shingles Vaccine, Shingrix®, Recommended Over Zostavax®
- Second CAR-T Therapy Receives FDA Approval: Yescarta®
- FreeStyle Libre® Offers Blood Glucose Readings Without Routine Fingersticks
- Approval of First Ingestible Digital Tracker: Abilify MyCite® (aripiprazole tablets with sensor)
- FDA Assessing if Uloric® (febuxostat) Increases the Risk of Heart Problems
- Semaglutide Receives Strong Recommendation from FDA Advisory Panel
- FDA Working to Minimize Impact of Intravenous Fluid Shortages
- Update on Carbidopa/Levodopa Extended-Release Tablet Shortage
- Update on Atenolol Shortage
New Shingles Vaccine, Shingrix®, Recommended Over Zostavax®
Shingles occurs when the varicella zoster virus (VZV) is reactivated in a patient previously infected with the VZV virus. The VZV virus is responsible for causing the childhood illness chickenpox, and nearly all older adults already have the virus in their body. As an individual ages reactivation of the virus is more likely to occur because the immune system may be unable to suppress the virus from replicating. In the United States, there are approximately one million cases of shingles each year with the vast majority of cases occurring in patients over the age of 50 years.
In October 2017, the U.S. Food and Drug Administration (FDA) approved a new vaccine for the prevention of shingles in adults aged 50 years and older: Shingrix® (zoster vaccine recombinant, adjuvanted). At the end of last month, the Advisory Committee on Immunization Practices (ACIP) voted 8 to 7 the newly FDA-approved Shingrix vaccine be preferred over the other shingles vaccine, Zostavax® (zoster vaccine live). ACIP also recommended patients previously vaccinated with Zostavax receive the Shingrix vaccine for the prevention of shingles and its complications. The Shingrix vaccine was recommended by ACIP for healthy adults aged 50 years and older for the prevention of shingles. If approved by the director of the Centers for Disease Control and Prevention (CDC), the ACIP recommendations will become official CDC policy.
The other shingles vaccine, Zostavax, is also indicated for the prevention of shingles in people 50 years and older. This vaccine is a live, attenuated virus administered as one lifetime dose subcutaneously (under the skin). In contrast, Shingrix is an inactive, recombinant, and adjuvanted vaccine that requires two intramuscular (into the muscle) doses given 2 to 6 months apart. Shingrix has been found to be 97% efficacious in adults 60 to 69 years old, 90% in adults 70 to 79 years old, and 89% efficacious in adults 80 years and older.
The FDA’s approval of Shingrix was based on a Phase III clinical trial program involving more than 38,000 patients. Researchers found Shingrix was more than 90% effective against preventing shingles in patients aged 50 years and older, and the response was sustained over a follow-up period of 4 years. Additionally, Shingrix reduced the occurrence of a type of chronic nerve pain called postherpetic neuralgia (PHN), a common complication of shingles. Patients should not receive Shingrix if they are allergic to any of its ingredients or have had a reaction to a prior dose of the Shingrix vaccine. Shingrix is not indicated for the prevention of chickenpox and may not protect all individuals from developing shingles. Common side effects are injection site irritation (including pain, redness, and swelling) as well as muscle pain, tiredness, headache, shivering, fever, and upset stomach. Patients should discuss the risks and benefits of Shingrix with a healthcare provider to determine if Shingrix is appropriate.
Shingrix became commercially available in late November and carries an average wholesale price of $336.00 for a two-dose series. In contrast, the AWP for the one-dose series of Zostavax is $267.74. NPS is planning to review Shingrix for placement on the national formularies in the near future. For more information about Shingrix, please visit www.shingrix.com.
New Specialty Drug Approval
Second CAR-T Therapy Receives FDA Approval: Yescarta®
On October 18, 2017, Yescarta® (axicabtagene ciloleucel) received FDA approval for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more systemic treatments. Yescarta is indicated specifically for diffuse large B-cell lymphoma (DLBCL), not otherwise specified, and primary mediastinal large B-cell lymphoma (PMBCL). This unique treatment is manufactured from a patient’s own harvested T cells that are genetically modified to contain a chimeric antigen receptor (CAR). The modified T cells with the new receptor are then infused back into the patient. Yescarta is the first CAR-T cell therapy indicated for the treatment of DLBCL and PMBCL.
DLBCL is a type of non-Hodgkin lymphoma (NHL) and is an aggressive, fast-growing cancer. The majority of non-Hodgkin’s lymphomas in the U.S. are B-cell lymphomas. These cancers usually begin in the lymph nodes of the neck, armpit, or groin. Depending on the severity of the cancer, National Comprehensive Cancer Network (NCCN) guidelines recommend chemotherapy, radiation therapy, stem cell transplants, and/or enrollment in clinical trials for treatment. According to Louis DeGennaro, PhD, President and Chief Executive Officer of The Leukemia & Lymphoma Society (LLS), Yescarta provides an option for patients who have previously tried and failed conventional treatments.
FDA approval of Yescarta was based on the ZUMA-1 trial in which 101 patients received the drug. In this Phase II, single-arm study, Yescarta-treated patients demonstrated a response rate of 72% with 51% of patients having no detectable cancer remaining following the therapy. After a median follow-up period of 7.9 months, patients achieving complete remission were exhibiting an ongoing positive response. Yescarta carries a black box warning (BBW) for cytokine release syndrome (CRS) and neurologic toxicities, both of which can be life-threatening or fatal. Due to these serious adverse effects, Yescarta has a Risk Evaluation and Mitigation Strategy (REMS) program and is only available through authorized treatment centers with training and supplies for the management of these serious side effects. Yescarta has a number of other side effects including: increased heart rate, low blood pressure, fatigue, headache, decreased appetite, chills, diarrhea, nausea, and others.
The manufacturer’s multi-disciplinary field team has begun to coordinate final site certification for authorized treatment centers across the U.S. The most current and up-to-date list of authorized treatment centers can be found on the manufacturer’s website: www.yescarta.com. This second CAR-T cell therapy is commercially available in the U.S. and carries an average wholesale price of $447,600 per one lifetime treatment course. Due to the specialized training and authorization required for administration of Yescarta, it is anticipated to be covered under the medical benefit. For additional details on the approval of Yescarta, please view the FDA’s press release.
New Device Approval
FreeStyle Libre® Offers Blood Glucose Readings Without Routine Fingersticks
On September 27, 2017, the FDA announced approval of the FreeStyle® Libre Flash Glucose Monitoring System as a replacement for blood glucose monitoring in adults with diabetes. This new product offers patients the convenience of a continuous glucose monitor (CGM) without the inconvenience of routine finger stick calibrations. The Centers for Disease Control and Prevention (CDC) released a report in July 2017 estimating more than 30 million people in the United States have type I diabetes (caused by insufficient insulin production) or type II diabetes (inability to use insulin properly). Extended periods of high blood sugar levels can lead to health complications, such as kidney disease or nerve pain.
The Freestyle Libre System has two components: a sensor and a hand-held reader. The sensor is approximately the size of two stacked quarters and can be self-applied to the back of the arm. It is water-resistant and can be worn while showering or swimming. Each new sensor requires a 12-hour start up after which it can be worn for up to 10 days. To display the current trending glucose level (indicated with an up or down arrow) and a graph of the past 8 hours, the patient waves the monitor over the sensor. The glucose reading displayed is determined by interstitial fluid glucose levels, and unlike other CGMs, will not be affected by acetaminophen use. The sensor will work with the reader while under clothing and does not require finger sticks to determine blood glucose levels.
A clinical trial evaluated the safety and efficacy of CGMs compared to traditional flash glucose-sensing technology. The study assessed differences in HbA1c (a measure for glucose control) at the end of a 6-month period, time spent in hypoglycemia (low blood sugar), and patient satisfaction. A total of 224 patients aged 18 years or older were enrolled in the study. Researchers concluded at 6 months there were no overall differences in HbA1c between the CGM and the flash glucose-sensing technology. However, the data for patients less than 65 years of age showed a larger reduction in HbA1c with CGM testing while the data for patients 65 years of age or older showed a larger decrease with flash glucose-sensing testing. The patients in the CGM group experienced less time in hypoglycemia compared to the flash glucose-sensing patients, and higher rates of satisfaction were also reported with CGM compared to the traditional glucose-sensing technology. No serious adverse events or severe hypoglycemic events occurred in either group of patients during the trial. Patients should verify sensor glucose readings with a blood glucose meter if they experience symptoms of high or low blood sugar that do not coincide with the glucose reading, the Check Blood Glucose symbol appears, or when readings may be inaccurate. The system does not provide real-time alerts and therefore will not alarm the user of high or low sugar levels without patient action. Mild skin irritation may occur at or around the insertion site.
Approval of the CGM from FreeStyle provides a blood glucose management tool that may be more favorable to patients with diabetes as it does not require routine finger sticks. Real-time glucose level readings as well as glucose trends are reported. While other CGMs on the market may require a finger stick at a minimum of twice per day to ensure the device is calibrated, the FreeStyle Libre system does not require daily calibration. FreeStyle expects Libre system to be available by prescription in major pharmacies before the end of 2017. For more information, please visit: www.freestylelibre.us.
New Drug Approval
Approval of First Ingestible Digital Tracker: Abilify MyCite® (aripiprazole tablets with sensor)
On November 13, 2017, the U.S. Food and Drug Administration (FDA) approved the first ingestible digital tracker: Abilify MyCite® (aripiprazole tablets with sensor). It is indicated for the treatment of schizophrenia, bipolar I disorder, and as an additional treatment for major depressive disorder (MDD). The Abilify MyCite system is a combination of an aripiprazole tablet with an embedded ingestible event marker (IEM), a wearable sensor called the MyCite® patch, the MyCite smart phone application (app), and a web-based portal for healthcare providers and caregivers. The system will help to provide information about medication habits to prescribers and patients. Mitchell Mathis, M.D., the director of the Division of Psychiatry Products with the FDA’s Center for Drug Evaluation and Research, believes that the ability to track medication use in this population of patients may be useful. However, the clinical impact of the Abilify MyCite system has not been fully established.
The Abilify MyCite tablet starts working when the IEM is exposed to the patient’s stomach acid. The MyCite patch will detect the IEM and transmit data including the date, time, and patient’s activity level to a smartphone. The MyCite app will allow patients the option of tracking subjective information such as mood and quality of rest. Patients are able to allow additional individuals access to the information entered into the app. Healthcare providers will have access to the app information via a web-based portal to help monitor patients and track patterns. Prior to use, prescribers should ensure the app is paired with the patch. The MyCite patch should be placed on the left side of the abdomen under the rib cage, on top of the stomach, and can be kept in place for up to a week. The majority of IEMs will be detected by the patch within 30 minutes of ingestion, though it may take up to two hours for the app or portal to reflect the data. There have been cases where the IEM is not detected at all. If this occurs, the patient should be instructed not to take another dose.
FDA approval of Abilify MyCite was based on data from multiple trials demonstrating the efficacy of aripiprazole in more than 13,000 patients with schizophrenia, bipolar I disorder, or major depressive disorder. The most common adverse effects occurring in ≥10% of adults receiving aripiprazole were nausea, vomiting, constipation, headache, dizziness, movement disorders, anxiety, insomnia, and restlessness. Skin irritation or localized skin rashes were experienced by 12.4% of patients where the MyCite patch was applied.
Abilify MyCite is expected to be available as an oral tablet in the following strengths: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. The recommended dosing is dependent on the indication for use and ranges from 2 to 15 mg daily. This first ingestible, digital tracker is expected to be available in 2018. Upon commercial availability, NPS is planning to review the product for placement on the national formularies. For additional information on Abilify MyCite, please view the FDA’s press release.
FDA Safety Update
FDA Assessing if Uloric® (febuxostat) Increases the Risk of Heart Problems
On November 15, 2017, the U.S. FDA released a safety warning for the gout medication Uloric® (febuxostat) based on the preliminary results of a recent safety study. An increased risk of heart-related death and death from all causes was observed with febuxostat use compared with another gout medication, allopurinol. The manufacturer of febuxostat, Takeda Pharmaceuticals, was required to conduct a safety trial when the drug was approved in 2009 based upon high rates of heart-related problems and stroke during pre-approval clinical trials. Febuxostat already carries a Warning and Precaution related to these cardiovascular events.
Febuxostat is FDA-approved to treat gout. Gout occurs when there is excess uric acid in the body. Too much uric acid can cause joint pain, redness, and swelling. Febuxostat works by reducing the levels of uric acid in the body. The safety trial evaluated 6,000 patients with gout being treated with febuxostat or allopurinol with a primary outcome of combined heart-related death, non-deadly heart attack, non-deadly stroke, and inadequate blood supply to the heart requiring surgery. Although these combined events were not increased for febuxostat compared to allopurinol, the individual outcomes for heart-related death and death from all causes were higher with febuxostat. The FDA encourages health care professionals to consider this information when deciding to prescribe or continue febuxostat. Patients should not stop taking febuxostat but are encouraged to discuss questions or concerns with their healthcare provider.
These study results are preliminary, and the FDA will review the final results and update the public when more information is available. Any adverse events experienced with febuxostat should be reported to FDA MedWatch Adverse Event reporting program online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088. To view the FDA Drug Safety Communication, please visit the FDA website.
Semaglutide Receives Strong Recommendation from FDA Advisory Panel
In October 2017, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 16 to 0 in favor of the approval of semaglutide. Semaglutide is a long-acting, once-weekly subcutaneous injection being reviewed for the management of glycemic control in adults with type II diabetes mellitus (T2DM) in combination with diet and exercise. It is an analog of human glucagon-like peptide-1 (GLP-1) and acts as a selective GLP-1 receptor agonist through stimulating insulin release and suppressing the release of glucagon. Novo Nordisk is pursuing approval for semaglutide 0.5 mg and 1 mg once-weekly subcutaneous injection doses. The FDA is not required to follow the Advisory Committee’s recommendation but takes the Committee’s recommendation into consideration during the review.
The New Drug Application (NDA) for once-weekly semaglutide is based on the safety and efficacy demonstrated with the SUSTAIN program. A total of over 8,000 participants were evaluated in this Phase III clinical trial program consisting of eight trials. The studies evaluated adults with type 2 diabetes, including those at high cardiovascular risk, with or without kidney disease. Semaglutide demonstrated superior blood glucose control to placebo and comparative medications, including sitagliptin, exenatide extended-release, and insulin glargine. Additionally, patients also experienced an average weight loss of 8 to 14 pounds while receiving semaglutide. In the SUSTAIN 6 trial, 3% of patients on semaglutide experienced retinopathy (damage to the retina of the eye) compared to 1.8% of patients on placebo. The Advisory Committee concluded that the risk of retinopathy should be included on semaglutide’s label but overall the medication was deemed to be safe. Results from the SUSTAIN program demonstrated the safety profile of semaglutide was comparable with that of other GLP-1 receptor agonists. The FDA is expected to make a decision regarding approval of semaglutide in December 2017. For additional information regarding the Advisory Panel’s recommendation, please view the manufacturer’s press release.
Drug Shortages and Discontinuations
FDA Working to Minimize Impact of Intravenous Fluid Shortages
The U.S. FDA announced in mid-November 2017, they are continuing to work with drug manufacturers in Puerto Rico affected by Hurricane Maria to address ongoing shortages of intravenous (IV) fluids. As a result of the damage to Baxter International’s facility responsible for production of IV fluids, the FDA may allow temporary importation from Baxter facilities outside of the U.S. as well as from B. Braun facilities in Germany. The FDA has also expedited the review of drug applications that may aid in alleviating these shortage issues and has recently approved Fresenius Kabi and Laboratorios Grifols saline products.
IV fluid shortage issues arose in 2014, and manufacturers have also been working to increase their production of these products in order to meet demands. In addition, to encouraging manufacturers with FDA-approved saline products to increase existing capabilities, the FDA has also pursued new manufacturing firms to begin production of these products. The FDA expects the shortage of IV fluids will decline and plans to continue their efforts to minimize the impact of these shortages. For additional information on the FDA’s efforts, please view the FDA news release.
Update on Carbidopa/Levodopa Extended-Release Tablet Shortage
The shortage of carbidopa/levodopa extended-release (ER) tablets has been ongoing since September 27, 2017. Carbidopa/Levodopa ER is indicated for the treatment of parkinsonism and Parkinson’s disease. Accord Healthcare Inc. currently has no product available for most strengths with a reported partial stock available only on the 50 mg/200 mg strength. Mylan Pharmaceuticals Inc. reported on November 13, 2017 that both strengths of 25 mg/100 mg and 50 mg/200 mg are currently available. On November 6, 2017, Sun Pharmaceuticals Inc. reported their 25 mg/100 mg strength is on short-term backorder. Merck Sharp & Dohme Corp.’s brand-name Sinemet CR 50 mg/200 mg is expected to be available through mid-November but the next batch is not expected to be released until early 2018; their 25 mg/100 mg strength is currently unavailable with the same early 2018 anticipated release date.
Update on Atenolol Shortage
The shortage of atenolol tablets has been ongoing since July 26, 2017. Atenolol is a selective beta-blocker used for several indications including: acute heart attack, chest pain, and high blood pressure. On November 8, 2017, Mylan Pharmaceuticals updated their anticipated availability date from unknown to February 2018, citing a shortage of active ingredient as the reason for the shortage. Sandoz’s anticipated resupply and inventory recovery status of ‘to-be-determined’ remains and was last verified on November 21, 2017. The availability of atenolol from Teva Pharmaceuticals and Zydus Pharmaceuticals has not been reverified since October 19, 2017. On that date, Teva listed a limited inventory of atenolol with allocation expected until late this year. Zydus listed availability of all strengths and has increased capacity to manage increased demand for the drug.
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