FDA Update: October 2018

Oct 26, 2018

Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Tiglutik Approved to Treat Amyotrophic Lateral Sclerosis

The FDA approved ITF Pharma’s Tiglutik (riluzole) oral suspension on Sept. 5, 2018. It is indicated to treat patients who have amyotrophic lateral sclerosis (ALS). In the United States, about 20,000 individuals have ALS, a progressive disease that destroys nerve cells in the brain and spinal cord. Patients who have it gradually lose the abilities to move, speak and even breathe. Because many patients who have ALS cannot swallow easily, Tiglutik is a thickened liquid form of the medication that is given by oral syringe. The few other treatments for ALS are either injections or oral tablets that have to be compounded into an oral liquid form. Recommended dosing is 50mg (10mL or about two teaspoons) once every 12 hours at least one hour before or two hours after a meal. Because Tiglutik can damage the liver, hepatic transaminase levels for patients taking it should be checked once a month for the first three months and then at regular intervals during therapy. To be dispensed in 300mL bottles, its launch is planned for mid-October. Pricing information has not yet been announced, but complete prescribing information is available here.

New Ophthalmic Drug, Xelpros, Approved

Xelpros (latanoprost ophthalmic emulsion – Sun Pharma) 0.005% was FDA approved on Sept. 12, 2018. A prostaglandin analogue that reduces elevated intraocular pressure (IOP), it is indicated for treatment of open-angle glaucoma and ocular hypertension. One drop is used in each affected eye once a day in the evening. Xelpros is the first latanoprost eye drop that does not include benzalkonium chloride (BAK), a common preservative. Instead, a proprietary formulation technology makes it dissolve better. As with all ophthalmic prostaglandins, using it may cause changes in eye and eyelid color. Eyelash properties, including length and thickness, also may be affected. In the U.S., Xelpros will be distributed by Sun Ophthalmics. Prescribing information can be found here.

Lumoxiti Approved to Treat Hairy Cell Leukemia

AstraZeneca’s immunotoxin, Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous (IV) use, was approved by the FDA on Sept. 13, 2018. It is indicated to treat adults who have hairy cell leukemia that recurs or resists treatment despite two or more rounds of systemic treatment, including therapy with a purine nucleoside analog. Hairy cell leukemia is a chronic form of leukemia that affects only about 500 new patients annually in the United States. Beginning in the bone marrow it causes the overproduction of B cells, which have a shaggy appearance when viewed under a microscope. Lumoxiti will be infused over one-half hour at a recommended dose of 0.04mg/kg on the first, third and fifth days of 28-day cycles for a maximum of six cycles. A boxed warning cautions that it may cause capillary leak syndrome and/or hemolytic uremic syndrome, which both may be fatal. AstraZeneca planned on launching Lumoxiti within four to six weeks. Prescribing information is located here.

Ajovy Approved to Prevent Migraines

Teva Pharmaceuticals received approval on Sept. 14, 2018, from the FDA for its migraine prevention drug, Ajovy (fremanezumab-vfrm). It is the second drug to be approved in its class, calcitonin gene-related peptide (CGRP) inhibitors. CGRP is a protein produced by nerve cells and involved in constricting blood vessels. Baseline levels of CGRP may be unusually high for individuals who have migraines. By blocking it, Ajovy helps prevent or lessen the vasoconstriction that often triggers migraines. Recommended dosing is one self-administered SC injection (225mg) once a month or three injections (675mg) given at the same time once every three months. Ajovy is available through open distribution. It is priced at about $575 per month – the same as Aimovig (erenumab-aooe – Amgen/Novartis), the only other CGRP inhibitor currently available on the U.S. market. They are not approved for acute treatment of migraine. Prescribing information is available here.

Authorized Generic Launched for Ampyra

Mylan launched an authorized generic for Ampyra® (dalfampridine – Acorda Therapeutics) on Sept. 21, 2018. Dalfampridine is indicated to improve walking for patients who have multiple sclerosis (MS). Approximately 1,000,000 patients in the U.S. have MS, a chronic central nervous system (CNS) condition that can cause a variety of symptoms including paralysis, loss of vision and cognitive impairments. Up to 85% of patients with MS experience difficulty with walking. At a recommended dose of 10mg twice daily, dalfampridine can be taken alone or used along with other drugs that treat MS. IQVIA estimated that U.S. sales for Ampyra were about $553 million for the 12-month period that ended on June 30, 2018. While no generic manufacturer has announced the launch of its A-rated generic to Ampyra, several have been approved according to FDA’s website.

Copiktra Approved for Leukemia and Lymphoma

On Sept. 24, 2018, Verastem received approval from the FDA for Copiktra (duvelisib) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. It also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. CLL/SLL and FL, which affect approximately 350,000 patients in the U.S., are common types of blood cancers known as indolent non-Hodgkin lymphomas. Patients oftentimes relapse and become refractory to currently-available therapies. Copiktra is an oral phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma inhibitor. The recommended dose of 25mg twice daily can be modified based on toxicity. Verastem launched Copiktra upon approval. Full prescribing information can be found here.

Emgality Approved for Migraine Prevention

Eli Lilly’s Emgality (galcanezumab-gnlm) was approved by the FDA on Sept. 27, 2018. The third calcitonin gene-related peptide (CGRP) inhibitor to enter the U.S. market, it is indicated to prevent migraine headaches for adults. During their headaches, about 90% of the estimated 39 million Americans who have migraines cannot participate normally in regular activities, such as school or work. Following a single loading dose of 240mg (two self-injections at the same time), one dose (120mg) of Emgality will be self-injected subcutaneously (SC) each month. It is available through open distribution. The annual WAC of all three FDA-approved CGRP inhibitors is $6,900. Complete prescribing information is available here.

Vizimpro Approved for Non-Small Cell Lung Cancer

On Sept. 27, 2018, the FDA approved Pfizer’s Vizimpro® (dacomitinib) tablets as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) that has epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. NSCLC, the most common form of lung cancer, affects around 190,000 new patients in the United States each year. However, only about 10% to 35% of patients with NSCLC also have an EGRF mutation. The most common activating mutations are deletions in exon 19 and exon 21 L858R substitution, which represent 80% of known activating EGFR mutations. Accelerated approval for Vizimpro was based on results of the ARCHER 1050 trial. Patients treated with Vizimpro had a median progression-free survival (PFS) time of 14.7 months compared with 9.2 months in the gefitinib (Iressa® - AstraZeneca) group. Recommended dosing is 45mg orally once daily, with or without food. Pfizer plans to launch Vizimpro within the next few weeks. Prescribing information is located here.

Epidiolex Scheduled

The U.S. Drug Enforcement Administration (DEA) announced on Sept. 27, 2018, that it classified GW Pharmaceutical’s Epidiolex® (cannabidiol) oral solution as a Schedule V (C-V) controlled substance. Epidiolex is indicated to treat patients at least two years old who have seizures related to Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). Schedule V, the least restrictive class of controlled substances, includes drugs with little potential for abuse, but proven medical uses. Other antiepileptic medications, such as Briviact® (brivaracetam) and Vimpat® (lacosamide) are C-V drugs, as well. GW plans to launch Epidiolex as soon as the company is licensed for distribution -- likely within the next six weeks. For prescribing information, please see here.

Arikayce Approved to Treat Mycobacterium Avium Complex Lung Disease

The FDA approved Arikayce® (amikacin liposome inhalation suspension – Insmed, Inc.) on Sept. 28, 2018. Also abbreviated as ALIS, Arikayce is an aminoglycoside antibiotic that is inhaled into the lungs once daily through a specialized device, the LamiraNebulizer System. It is indicated for use in combination with other antibacterial drugs to treat adult patients who have few or no options to treat a rare lung disease caused by Mycobacterium avium complex (MAC) despite six months or longer of standard multi-drug treatment. Currently, two or three antibacterial drugs from different classes are used together for a year or longer to treat MAC lung disease. Injectable amikacin may be part of the regimen, but it can damage hearing, kidney function and nerves. Delivering aerosolized amikacin straight into the lungs can reduce the risk of systemic side effects. However, it has a boxed warning about the potential for serious respiratory effects, including hypersensitivity pneumonitis. It will be released in the next few weeks at a WAC of approximately $132,000 per year. Prescribing information is located here.

Libtayo Approved for Cutaneous Squamous Cell Carcinoma

Libtayo® (cemiplimab-rwlc) was FDA approved on Sept. 28, 2018. Jointly developed by Regeneron Pharmaceuticals and Sanofi, it is a monoclonal antibody that is indicated to treat metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. The first drug approved to treat advanced CSCC, it will be given as 30-minute intravenous (IV) infusions once every three weeks for patients who cannot have surgery or radiation. It will be dispensed with a Medication Guide that warns of possible immune-related adverse effects, including colitis, hepatitis, nephritis and pneumonitis, that it may cause. Libtayo was launched upon approval. Complete prescribing information for it is here.

New Testosterone Replacement Product Approved

Xyosted™ (testosterone enanthate – Antares Pharma) injection was approved by the U.S. Food and Drug Administration on Sept. 28, 2018. Indicated to replace testosterone for men who have primary or hypogonadotropic hypogonadism resulting from genetic or structural reasons, it is not intended to treat low testosterone due to aging. It has not been tested for patients younger than 18. Self-injected subcutaneously (SC) once a week, it will be available before the end of the year in 50mg. 75mg, 100mg strengths. Like all testosterone products, it is a Schedule III controlled substance and it carries a boxed warning that using testosterone can raise blood pressure, possibly raising the risk of a heart attack or stroke. Patients using Xyosted should be checked frequently for hypertension. Complete prescribing information is here.

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