Generic Copaxone Approved
On Oct. 3, 2017, Mylan received approval from the U.S. Food and Drug Administration (FDA) for glatiramer injection 40mg/mL, the first A-rated generic to Teva’s Copaxone® 40mg/mL. At the same time, Mylan’s 20 mg/mL glatiramer also was approved. Both are used to treat relapsing multiple sclerosis (RMS) with the 40mg/mL strength self-injected subcutaneously three times a week and the 20mg/mL strength used daily. As one of the first applications to file for a generic to Copaxone 40mg/mL, the company may be eligible for “shared” generic exclusivity for this strength. While the company has indicated that the launch is imminent, formal launch plans have not been released. Full prescribing information is not yet available.
Generic Toviaz Approved
On October 5, 2017, the generic for Toviaz, fesoterodine fumarate extended-release capsules, was approved by the FDA. Available in 4mg and 8mg strengths, fesoterodine fumarate is used to manage overactive bladder symptoms such as urinary frequency. Launch plans are not yet final.
New Strength Approved for Ingrezza
On October 5, 2017, the Food and Drug Administration (FDA) approved a new dosage strength for Ingrezza. Indicated for the treatment of adults with tardive dyskinesia, Ingrezza will now be available as an 80mg capsule, it is currently available as a 40mg capsule. Recommended dosing for Ingrezza is 40mg per day for the first week, then an increase to 80mg once a day. Neurocrine Biosciences plans to release the new strength within two weeks.
Lyrica CR approved for Two Neuropathic Pain Conditions
On On October 12, 2017, the Food and Drug Administration (FDA) approved Lyrica, a once-daily treatment for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). Lyrica CR is a Schedule V controlled substance and not approved for fibromyalgia or seizures. It will be available in 82.5mg, 165mg, and 330mg tablets strengths. Its recommended dosing is 165mg after the evening meal. If needed, doses can be increased to as much as 330mg/day for DPN or up to 660mg/day for PHN. Pfizer expects to launch it in January 2018.
Zilretta Approved to Treat Osteoarthritis Knee Pain
On October 10, 2017, the FDA approved Zilretta, the first extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta combines triamcinolone acetonide (TCA), a short-acting corticosteroid, with a poly lactic-co-glycolic acid (PLGA) matrix to provide pain relief over 12 weeks. It is to be administered by specialists, such as rheumatologists and orthopedists, in an office or clinic setting. Zilretta is expected to list at a cost of about $570 per injection. Flexion Therapeutics plans to start introducing it in the next few weeks, with a full launch later in the year.
Yescarta approved to Treat Adult Patients with non-Hodgkin lymphoma
Yescarta™ (axicabtagene ciloleucel), a chimeric antigen receptor (CAR)-T treatment for specific types of lymphoma, was approved by the U.S. Food and Drug Administration (FDA) on Oct. 18, 2017. The gene therapy is indicated to treat adult patients with relapsed or refractory forms of non-Hodgkin lymphoma (NHL), which include diffuse large-B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) or transformed follicular lymphoma (TFL) that already has been treated at least twice with other drugs. Yescarta will be administered in certified facilities by healthcare professionals trained in its use.
Stelara Approved to Treat Adolescent Patients With Plaque Psoriasis
On On October 16, 2017, the Food & Drug Administration (FDA) approved Stelara for the treatment of patients aged ≥12 years with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Stelara, a fully human interleukin (IL)-12 and IL-23 antagonist, is already approved to treat adults with moderate or severe psoriasis who may benefit from systemic or phototherapy. It is also indicated to treat adults aged ≥18 years with active psoriatic arthritis, alone or in combination with methotrexate, and for the treatment of active Crohn’s disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or, failed or were intolerant to treatment with ≥1 TNF blockers.
Bydureon BCise Gets FDA Approval for Type 2 Diabetes
On October 23, 2017, the FDA approved Bydureon BCise (exenatide extended-release injectable suspension) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This new formulation of Bydureon (exenatide extended-release) allows for once-weekly administration because of its continuous-release microsphere delivery system designed to provide consistent therapeutic levels of exenatide. As the product is intended for self-administration, clinicians should train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Prior treatment with an immediate- or extended-release exenatide product is not required when initiating Bydureon BCise. Patients should discontinue treatment with other exenatide products before starting treatment. Bydureon BCise, a glucagon-like peptide-1 (GLP-1) receptor agonist, is supplied as 2mg of exenatide per 0.85mL suspension in a pre-filled disposable single-dose autoinjector. It is expected to be available in the first quarter of 2018.
New Hepatitis B Vaccine Gains Approval
On November 10, 2017, the Food & Drug Administration (FDA) approved Heplisav-B for the prevention of infection caused by all known subtypes of hepatitis B virus. Heplisav-B is approved for use in adults 18 years of age and older. Heplisav-B is administered by intramuscular injection in two doses one month apart. Currently available hepatitis B vaccines require more doses to be administered over longer times. Heplisav-B is expected to be available in the first quarter of 2018. Each 0.5mL dose is formulated to contain 20mcg of HBsAg and 3000mcg of CpG 1018 adjuvant.
Cinvanti Approved for Chemotherapy-Induced Nausea and Vomiting
On November 10, 2017, the FDA approved Cinvanti in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin; and for nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Cinvanti, a substance P/neurokinin-1 (NK1) receptor antagonist, is an injectable emulsion for intravenous (IV) infusion that helps address the low water solubility of aprepitant without the addition of polysorbate 80 or other synthetic surfactants. Polysorbate 80 has been associated with hypersensitivity reactions such as anaphylaxis and irritation of blood vessels. Cinvanti will be available as a 130mg/18mL strength emulsion for IV infusion in single-dose vials. It is anticipated to be available on January 3, 2018.
Zelboraf Approved to Treat Rare Blood Cancer
On November 6, 2017, the FDA approved Zelboraf (vemurafenib) for the treatment of adults with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. ECD is a rare and serious blood disease characterized by the abnormal multiplication of histiocytes. Zelboraf, a kinase inhibitor, is also indicated for the treatment of unresectable melanoma or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Alecensa Receives Approval for New Indication
On November 6, 2017, the FDA approved Alecensa (alectinib) as a first-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. In addition, the FDA granted full approval to Alecensa for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib. Alecensa, a kinase inhibitor, is available in 150mg capsules.
Auryxia Approved for New Indication
On November 7, 2017, the FDA approved Auryxia (ferrous citrate) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD) who are not on dialysis. Auryxia is already approved for the control of serum phosphorus levels in patients with chronic kidney disease who require dialysis.
New Indication for Adcetris
On November 9, 2017, the FDA approved Adcetris (brentuximab vedotin) for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Adcetris, a CD30-directed antibody-drug conjugate, is already indicated for the treatment of classical Hodgkin lymphoma (cHL) patients who fail autologous hematopoietic stem cell transplantation (auto-HSCT) or who fail ≥2 prior multi-agent chemotherapy regimens and are not auto-HSCT candidates and for the treatment of patients with cHL at high risk of relapse or progression as post-auto-HSCT consolidation. The drug was also granted accelerated approval for the treatment of systemic anaplastic large cell lymphoma (sALCL) patients who fail at least one prior multi-agent chemotherapy regimen. Adcetris is available as a 50mg/vial lyophilized powder for intravenous (IV) infusion in single-use vials.
New Pediatric Indication for Sprycel
On November 10, 2017, the FDA approved Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Previously, Sprycel was granted Priority Review and Orphan Drug Designation for this indication. Sprycel, a tyrosine kinase inhibitor, is already indicated for chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
Vimpat Approved to Treat Partial-Onset Seizures in Children
On November 6, 2017, the FDA approved Vimpat (lacosamide) for the treatment of partial-onset seizures in pediatric patients ≥4 years old. As the safety of Vimpat injection has not been established in pediatric patients, this approval is only for the oral solution or tablet formulations. Its intravenous (IV) form is not recommended for patients under the age of 18 years, but both oral tablets and an oral solution are available. For children and teens, doses are taken twice daily at amounts determined by the patient’s weight.
Hemlibra® approved for routine prophylaxis to prevent or reduce bleeding episodes
On Nov. 16, 2017, the U.S. Food and Drug Administration (FDA) approved Genentech’s Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called factor VIII inhibitors. The recommended dose is 3 mg/kg injected under the skin (subcutaneously) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly.
FDA Approves Antipsychotic Agent With Sensor to Track Ingestion
On November 14, 2017, the Food & Drug Administration (FDA) approved Abilify MyCite (aripiprazole tablets with sensor), the first digital medicine system that tracks if patients have ingested their medication. Abilify MyCite is indicated for the treatment of schizophrenia, Bipolar I disorder (acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate; and maintenance treatment as monotherapy, and as adjunct to lithium or valproate) and adjunctive treatment of major depressive disorder. Web-based dashboards are available for healthcare providers and caregivers to monitor the patient’s aripiprazole ingestion over time. The system also obtains data on activity level, and self-reported rest and mood that can be shared with caregivers and family as well as healthcare providers. Patients can stop sharing data or opt out of the program at any time. Abilify MyCite is designed to track drug ingestion; it is not recommended for tracking in “real-time” or emergency situations as it may take 30 to 120 minutes to detect tablet ingestion. Prior to initial patient use, clinicians should facilitate use of the combination product and its components (patch, app, portal) to ensure that the patient is capable and willing to use smartphones and apps. Abilify MyCite will be available as 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg strength tablets with sensor in 30-count bottles co-packaged with 7 patches. The product is anticipated to launch in 2018.
Vraylar Approved as Maintenance Treatment for Schizophrenia
On November 13, 2017, the FDA approved Vraylar (cariprazinez) for the maintenance treatment of adults with schizophrenia. Vraylar is already approved for the acute treatment of schizophrenia and the acute treatment of manic or mixed episodes of bipolar I disorder in adults. Vraylar is taken once a day with a recommended daily dose range between 3mg and 6mg. The risk of death increases when it is used by elderly patients who have psychoses associated with dementia, so a boxed warning cautions against use for older patients. It also is not indicated for pediatric use.
Faslodex Approved as Combo Treatment for Advanced Breast Cancer
On November 15, 2017, the FDA approved Faslodex (fulvestrant) for use with abemaciclib, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy. Common adverse reactions seen with Faslodex + abemaciclib vs. Faslodex + placebo were diarrhea, neutropenia, fatigue, nausea, infections, abdominal, pain, anemia, leukopenia, decreased appetite, vomiting, and headache. Faslodex, an estrogen receptor antagonist, was initially approved in 2002 for postmenopausal women with HR+ advanced breast cancer with disease progression following endocrine therapy. Then in 2016, it was approved for use with palbociclib, for the treatment of women with HR+, HER2- advanced or MBC, whose cancer has progressed after endocrine therapy. In August 2017, it was approved for the treatment of HR+, HER2- advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
MedWatch Update Uloric
Based on interim results from a study of the gout drug, Uloric (febuxostat – Takeda), the FDA issued a Safety Communication on Nov. 15, 2017. In a post-marketing clinical trial that involved more than 6,000 patients, those taking Uloric had a higher chance of dying from a heart condition, such as a heart attack or stroke, than patients taking another gout drug, allopurinol. Although the relative numbers of non-fatal cardiovascular events did not differ significantly between the two groups, the overall risk of death for any reason was increased among the ones taking Uloric, as well. Patients who take it are advised to discuss possible alternatives with their health providers. The FDA will release further information when the final results of the study and related data are available.
Enbrel Mini With AutoTouch Now Available
On November 17, 2017, Amgen announced the availability of the Enbrel (etanercept) Mini with AutoTouch, a new delivery system for the administration of etanercept. The AutoTouch is designed to be used with Enbrel Mini single-dose prefilled 50mg/mL cartridges which include a new formulation of Enbrel. A Phase 3b multicenter trial showed that the new formulation of Enbrel resulted in a significant reduction in injection site pain compared to the current formulation. The design of the AutoTouch includes an ergonomic handle, a needle that stays hidden during injection, and a sensor that detects placement on the skin. It also includes 3 different injection speeds, a progress bar and a speaker. Enbrel, a tumor necrosis factor (TNF) blocker, is approved to treat several conditions including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. The Enbrel Mini with AutoTouch was approved by the Food and Drug Administration in September 2017.
Auvi-Q 0.1mg Auto-Injector Approved for Infants, Small Children
On November 20, 2017, the FDA approved the use of Auvi-Q (epinephrine injection) 0.1mg Auto-Injector for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5–33lbs (7.5–15kg) who are at risk for or have a history of serious allergic reactions. Auvi-Q is a compact auto-injector with an electronic voice instruction system that guides the user through the delivery process; the needle also automatically retracts after administration. The new 0.1mg dose features a shorter needle and a lower epinephrine dose than the currently approved 0.15mg and 0.3mg epinephrine auto-injectors. Auvi-Q is already available as 0.15mg and 0.3mg strength auto-injectors. The new 0.1mg dose is anticipated to launch in the first half of 2018.