FDA Update: January 2018

Jan 9, 2018
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Last month, the U.S. Food and Drug Administration (FDA) approved a number of new drugs, biosimilars, indications and generics, including several of particular interest as designated by the Emerging Therapeutics team:

FDA Approves Ogivri, a Biosimilar to Herceptin

On Dec. 1, 2017, the FDA approved Mylan and Biocon’s Ogivri (trastuzumab-dkst), a biosimilar to Genentech’s Herceptin® (trastuzumab). Ogivri was approved for both Herceptin-approved indications -- for treating patients with either breast cancer or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It is administered as an intravenous (IV) infusion. The dose of Ogivri varies depending on the indication. Launch information is not available at this time. Full prescribing information is available here.

Repatha Approved for Cardiovascular Protection

Repatha® (evolocumab – Amgen) was FDA approved on Dec. 1, 2017, for decreasing the chance of cardiovascular (CV) events among patients who have CV disease. In a large clinical trial, the risk of heart attacks and strokes was reduced by 27% and 21%, respectively, for patients using Repatha along with appropriate statin doses as compared with patients using a placebo and a statin. A proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, it was first approved in 2015 for treating patients who have heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH) or clinical atherosclerotic CV disease (ASCVD) that requires additional lowering of low-density lipoprotein cholesterol (LDL-C) despite diet changes and maximum doses of other LDL lowering therapies, such as statins. The recommended doses for Repatha are 140mg once every two weeks or 420mg once every month by subcutaneous (SC) injection. It is available in pre-filled syringes and autoinjectors containing 140mg each or as an on-body infuser, which holds 420mg in a 3.5mL cartridge of solution that is delivered over nine minutes. Full prescribing information can be found here.

Ozempic Approved for Diabetes

On Dec. 5, 2017, Novo Nordisk received approval from the FDA for Ozempic® (semaglutide) injection. The drug is a long-acting glucagon-like peptide-1 (GLP-1) agonist that is self-administered as a once-weekly SC injection for treating adults with type 2 diabetes. The recommended starting dose is 0.25mg once weekly for at least four weeks of therapy, and then increased to 0.5mg once weekly. If, after at least four weeks, additional glycemic control is needed, the dose can be increased to one mg once weekly. The company is planning on launching the Ozempic single-patient-use pre-filled pen injectors during the first quarter of 2018. Two pen devices will be available, one designed to administer 0.25mg or 0.5mg/injections and one that delivers one mg/injection. Prescribing information is available on the company’s website here.

Generic Launched for Viagra

The first generic for Viagra® (sildenafil – Pfizer) was launched in the United States on Dec. 11, 2017. Viagra is a phosphodiesterase-5 (PDE-5) inhibitor used to treat erectile dysfunction (ED). Due to patent lawsuit settlements, Teva can market its generics for all three strengths (25mg, 50mg and 100mg tablets) with 180 days of exclusivity. Pfizer is also releasing an authorized generic through its Greenstone generics division. Other generics will be allowed to enter the U.S. market on June 9, 2018. For 2017, sales of Viagra in the United States were expected to total $1.4 billion. More information about the generic can be found on Teva’s website here.

FDA Approves First Follow-On for Humalog

Sanofi’s Admelog® (insulin lispro injection) 100 Units/mL was FDA approved on Dec. 11, 2017. A rapid-acting insulin comparable, but not identical, to Humalog® (insulin lispro injection, 100 Units/mL – Lilly), Admelog is used to manage blood sugar levels for individuals who have diabetes. It is indicated to treat adults who have type 2 diabetes and patients as young as three years old who have type 1. It will be available early in 2018 as 10mL vials and pre-filled, disposable SoloStar® pen devices that hold 3mL of Admelog. For SC self-administration using a syringe or pen device. It should be given immediately before or after a meal. Admelog also can be delivered through an insulin pump or by IV injection. Prescribing information for Admelog is available here.

Third Biosimilar Approved for Remicade

Pfizer received FDA approval for Ixifi™ (infliximab-qbtx) on Dec. 13, 2017. It is the third approved biosimilar to Janssen’s Remicade® (infliximab). Ixifi is indicated to treat the inflammatory conditions ankylosing spondylitis, Crohn's disease (for both adults and children), plaque psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. Infliximab blocks tumor necrosis factor alfa (TNFα) to interfere with inflammation. It is administered by IV infusion at doses and schedules that differ according to the condition being treated. As with other TNF drugs, the labeling for Ixifi has a boxed warning that using it may increase the risk of serious bacterial or fungal infections that include tuberculosis (TB). Children and teens who use it may be more likely to have lymphoma or other cancers. Currently, Pfizer does not plan to release Ixifi in the United States. Prescribing information can be found here.

Generic to Viread 300mg Launched

On Dec. 15, 2017, Teva Pharmaceuticals announced the launch of its AB-rated generic to Gilead’s Viread® (tenofovir disoproxil fumarate) 300mg tablets. Viread is a nucleotide analog HIV-1 reverse transcriptase inhibitor (NRTI) approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients two years of age and older. Viread is also an HBV reverse transcriptase inhibitor approved for the treatment of chronic hepatitis B in adults and pediatric patients who are at least 12 years old.

New Glaucoma Drug Approved

Rhopressa® (netarsudil ophthalmic solution) 0.02% was approved by the FDA on Dec. 18, 2017. It reduces intraocular pressure (IOP) for patients who have open-angle glaucoma or ocular hypertension. It is the first in the class of rho kinase inhibitors, drugs believed to increase filtration from the eyes through the trabecular mesh. Small areas of spongy tissue in the front of the eyes, trabecular meshworks drain fluids from the eyes into blood vessels. Rhopressa also may decrease the production of fluid inside the eye and/or prevent fiber buildup in the trabecular regions. Aerie Pharmaceuticals plans to launch Rhopressa in the second quarter of 2018. Recommended dosing is one drop into each affected eye every evening at least five minutes before or after any other eye drops that the patient is using. It will be dispensed in 4mL plastic bottles that contain 2.5mL of solution. Its full prescribing information may be found at here.

Luxturna Ophthalmic Gene Therapy Approved

The FDA approved Spark Therapeutics’ Luxturna™ (voretigene neparvovec-rzyl) on Dec. 19, 2017. It is a unique gene therapy indicated to treat confirmed biallelic RPE65 mutation-associated retinal dystrophy, a rare genetic condition in which patients with the mutations gradually lose vision. Many patients ultimately become totally blind. Luxturna must be injected into the subretinal space by an ophthalmic surgeon. It is given once into one affected eye and then six days to 18 days later into the other eye. Using a viral vector, it transfers intact copies of the RPE65 gene directly behind the retina. Retinal surgeons trained by Spark Therapeutics will be administering Luxturna at selected treatment centers. Spark plans on launching Luxturna in the first quarter of 2018.

Steglatro Approved for Type 2 Diabetes

On Dec. 20, 2017, the FDA approved Merck and Pfizer’s Steglatro™ (ertugliflozin), for use in combination with diet and exercise to improve glycemic control in adults who have type 2 diabetes. Steglatro is the fourth approved product belonging to a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Drugs in the class work by blocking reabsorption of glucose by the kidneys; thereby increasing glucose excretion in the urine and lowering blood glucose levels. The recommended starting dose is 5mg once daily, taken in the morning with or without food. The dose can be increased to 15mg once daily in those tolerating the drug and requiring additional glycemic control. At the same time, the FDA also approved Segluromet™ and Steglujan™, which are ertugliflozin combinations with metformin and Januvia® (sitagliptin – Merck), respectively. Full prescribing information is available on the Merck website here.

Drug Approved to Diagnose Adult Growth Hormone Deficiency

The FDA approved Macrilen® (macimorelin) on Dec. 20, 2017, as a diagnostic agent for adults suspected of having growth hormone deficiencies. A ghrelin agonist, it prompts the pituitary gland to produce growth hormone. By measuring the amounts of growth hormone in the blood four times during the one and one-half hours after Macrilen is taken, accurate growth hormone levels can be determined. Current testing requires an IV insulin tolerance test with multiple blood draws over several hours; blood sugar levels need to be in the hypoglycemic range for correct test results. Macrilen will be dispensed as individual pouches each containing granules totaling 60mg of active drug. Each packet is dissolved in 120mL (about one-half cup) of water before ingestion. Patients being tested must not eat for at least eight hours before taking a single dose of 0.5mg/Kg of body weight. The manufacturer, Aeterna Zentaris, plans a launch in the first quarter of 2018. Prescribing information for Macrilen is available here.

Sickle Cell Drug, Siklos, Approved

Under priority review and with orphan status, Siklos (hydroxyurea – Addmedica) tablets received FDA approval on Dec. 21, 2017. The first sickle-cell drug with a pediatric indication, it reduces the rates of both painful crises and blood transfusions for pediatric patients who are at least two years old and who experience moderately to severely painful sickle cell crises. Recommended dosing is 20mg/Kg of body weight once a day. Doses may be increased when a crisis occurs or once every eight weeks, if needed, to a maximum of 35mg/Kg/day. As outlined in a boxed warning on its label, blood counts should be checked every two weeks because Siklos can decrease the ability of bone marrow to produce blood cells. It carries an additional boxed warning that it can cause cancer, as well. No launch or pricing plans have been made public. For prescribing information, click here.

Generic for Reyataz Launched

Teva Pharmaceutical Industries launched a generic for Reyataz® (atazanavir) capsules on Dec. 27, 2017. It is a once-daily protease inhibitor that is used in combination with other drugs to treat HIV-1 infection for patients who are at least six years old and who weigh at least 15Kg (about 33 pounds). U.S. sales of Reyataz were estimated at $402 million for the 12-month period that ended on Oct. 31, 2017.

Generic for Estrace Vaginal Cream

On Dec. 29, 2017, Mylan launched its estradiol vaginal cream, 0.01% immediately after approval by the FDA. Indicated to treat symptoms of vulvar and vaginal atrophy due to menopause, it is AB rated to Allergan’s Estrace® Cream. Recommended dosing is 2Gm to 4Gm applied vaginally once a day for up to two weeks. Doses should then be tapered to a maintenance dose of one Gm one to three times per week. Estradiol vaginal cream can be used alone or in combination with a progesterone replacement product. Treatment should be reviewed frequently and restricted to the shortest duration feasible based on individual outcomes and risks. All estrogens, including estradiol vaginal cream, carry a boxed warning that using them may increase the risk of having breast or endometrial cancer. They should not be used, either alone or with a progestin, to prevent CV diseases or dementia. For the 12-month period ending on Oct. 31, 2017, IQVIA (formerly QuintilesIMS) estimated U.S. sales of Estrace Vaginal Cream at $449 million.

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