FDA Update: July 2018

Jul 25, 2018

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

 New Pill Bottle



Express Scripts’ Emerging Therapeutics team features several of the important actions taken by the U.S. Food and Drug Administration (FDA):

Olumiant Approved for Rheumatoid Arthritis

Olumiant® (baricitinib), a Janus kinase (JAK) inhibitor, was approved by the FDA on May 31, 2018. It is indicated to treat adults who have moderately to severely active rheumatoid arthritis (RA) that has not been well managed by treatment with one or more tumor necrosis factor inhibitors. Recommended dosing is one tablet (2mg) daily -- either alone or along with a non-biologic disease-modifying anti-rheumatic drug, such as methotrexate. Lilly planned to launch Olumiant by the end of June. Full prescribing information is available here.

Fulphila Biosimilar for Neulasta Approved

The FDA approved Fulphila (pegfilgrastim-jmdb – Mylan/Biocon) on June 4, 2018. The first biosimilar for Neulasta® (pegfilgrastim - Amgen) to be approved in the U.S., it is indicated to decrease the risk of infections for patients who are receiving cancer drugs that interfere with the bone marrow’s production of blood cells and that are associated with a clinically significant incidence of febrile neutropenia. Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog filgrastim, giving it a longer duration of action. G-CSF causes cells in bone marrow to produce more neutrophils – white blood cells that protect against infections.

Fulphila will be given as one subcutaneous dose during each round of chemotherapy (chemo). It is administered at least one day after chemo is completed and at least 14 days before the next treatment. Fulphila is not interchangeable with Neulasta. However, the two products have no clinically significant differences in safety, purity or effectiveness. Fulphila’s complete prescribing information currently is available at the FDA website.

Rituxan Approved to Treat Pemphigus Vulgaris

Genentech’s Rituxan® (rituximab) was FDA approved for the treatment of adults with moderate to severe pemphigus vulgaris (PV) on June 7, 2018. PV is an autoimmune disease that affects between 30,000 and 40,000 Americans. It is a painful and potentially life-threatening condition that is associated with progressive blistering of the skin and mucous membranes. Rituxan is a CD20-directed monoclonal antibody that is also indicated to treat certain patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Its recommended initial dose for PV is two-1000mg intravenous (IV) infusions separated by two weeks and given in combination with a tapering course of glucocorticoids. For maintenance, one 500mg IV infusion is administered at month 12 and then followed by one every six months thereafter. Dose scheduling may be adjusted based on clinical evaluation. Rituxan’s full prescribing information is here.

Moxidectin Approved for River Blindness

The FDA approved moxidectin on June 13, 2018. It is an antiparasitic drug to treat onchocerciasis (river blindness) for patients 12 years of age and older. This tropical disease is caused by the parasitic worm, Onchocerca volvulus, deposited in human skin by the bites of infected blackflies. Infection can result in severe inflammation of the skin, enlarged lymph nodes and, in some patients, visual disturbances that ultimately can lead to blindness. Nearly 200 million people are estimated to be at risk for the disease. Although onchocerciasis occurs in Yemen and small areas of South and Central America, more than 99 percent of people who have it live in sub-Saharan Africa. Recommended dosing is 8mg, administered as a single dose of four 2mg tablets. The FDA approval was given to Medicines Development for Global Health, a non-profit biopharmaceutical company that produces medicines to address unmet needs in low- and middle-income countries. Pricing and availability are not known at this time. Full prescribing information can be found here.

Generics to Suboxone Sublingual Film Approved

Two manufacturers, Dr. Reddy’s and Mylan, announced approval of their first AB-rated generics to Indivior’s Suboxone® (buprenorphine/naloxone) sublingual (SL) film (CIII). They were approved by the FDA on June 14, 2018, for the maintenance treatment of opioid dependence. Buprenorphine is a partial-opioid agonist that helps to suppress withdrawal symptoms. Naloxone, as an opioid antagonist, blocks the effects of opioids. The drug must be used as part of a complete treatment plan that includes counseling and psychosocial support. Dr. Reddy’s revealed plans for an “at risk” launch. U.S. sales of Suboxone Film amounted to $1.86 billion for the 12 months ending April 2018, according to IQVIA.

Keytruda Label Expanded

During the week of June 11, 2018, the FDA approved two additional indications for Merck’s Keytruda® (pembrolizumab), an infused human programmed death receptor-1 (PD-1)-blocking antibody. Under its accelerated approval program, the FDA approved Keytruda to treat adult and pediatric patients who have primary mediastinal large B-cell lymphoma (PMBCL) that is not responding to other treatment or that has relapsed after two or more prior lines of therapy. PMBCL is a type of non-Hodgkin lymphoma. Also under accelerated approval, the FDA approved Keytruda for the treatment of patients who have recurrent or metastatic cervical cancer with disease progression on or after chemo and whose tumors express PD-L1 as determined by an FDA-approved test. Originally approved in 2014 to treat advanced melanoma, Keytruda also has indications for several other cancer types. Full prescribing information for Keytruda can be found here.

Nocdurna Approved for Nocturnal Polyuria

Nocdurna® (desmopressin acetate) was approved by the FDA on June 21, 2018. The first sublingual form of the drug, it is dissolved under the tongue without water. Nocdurna is indicated to treat adults who have nocturnal polyuria – the need to urinate at least twice during the night. It is taken once daily about one hour before bedtime. Women will take a lower dose (27.7mcg) than men (53.3mcg). A boxed warning cautions that using it may cause hyponatremia (low sodium levels in the blood). Sodium levels should be checked before treatment begins, within one week after starting Nocdurna, about a month later and then at regular intervals. It should not be used by individuals who are taking loop diuretics or corticosteroids. Ferring Pharmaceuticals plans to launch it in the second half of 2018. Its complete prescribing information is here.

Cinryze Label Expansion

On June 21, 2018, Shire announced that the FDA had approved Cinryze® (C1 esterase inhibitor [human]) for children as young as six years old. Originally approved in October 2008, it previously was indicated only to help prevent attacks of hereditary angioedema (HAE) for patients 12 years of age and older. HAE is an orphan disease with fewer than 10,000 patients in the U.S. A genetic disorder due to a deficiency of C1 inhibitor, it causes painful, recurrent, unpredictable and potentially life-threatening swelling of the abdomen, arms, face, legs, throat and urogenital tract. Its pediatric indication is based on a study of 12 patients between the ages of seven years and 11 years who received Cinryze every three or four days for 12 weeks. It is infused IV over a 10-minute period. Compared to the number of HAE attacks they had in the 12 weeks before being treated, children who received 500 Units of Cinryze  averaged a 71.1 percent decrease in attacks and those receiving 1,000 Units had an 84.5 percent decrease. Additionally, attacks not only tended to be milder, they generally needed less acute treatment, as well. Cinryze is not indicated to treat acute HAE attacks. Updated prescribing information is here.

First FDA-approved Derivative of Cannabis Approved for Rare Types of Epilepsy

Epidiolex® (cannabidiol) oral solution was approved by the FDA on June 25, 2018. The first FDA-approved derivative of Cannabis sativa (marijuana), it is believed to modulate several transporters and receptors involved in epilepsy. It is indicated to treat two rare forms of the condition, Lennox-Gastaut syndrome and Dravet syndrome, for patients as young as two years old. Recommended initial dosing is 2.5mg/kg twice a day (5 mg/kg/day). After one week, doses may be increased by 2.5mg/kg per dose (5mg/kg/day) at weekly intervals, if needed. The maximum dose is 10mg/kg twice daily (20mg/kg/day). As a controlled substance, Epidiolex will be scheduled through the Drug Enforcement Agency, which the manufacturer, GW Pharmaceuticals, has estimated will take approximately three months. Complete prescribing information is available here.

Zemdri Approved to Treat Urinary Tract Infections

The FDA approved Zemdri™ (plazomicin - Achaogen, Inc.) on June 25, 2018. An antibacterial drug in the aminoglycoside class, Zemdri is indicated to treat complicated (associated with predisposing conditions) urinary tract infections for patients age 18 and older. A second indication, to treat blood infections, was not approved because the number of participants in the clinical trial was too small to reach a definite conclusion on its effectiveness. Aminoglycoside antibacterials all have boxed warnings that they may injure the kidneys, damage hearing, interfere with nerve-to-muscle impulses and hurt developing fetuses. To help minimize the development of bacterial resistance, Zemdri should be used only after other antibiotics have failed to control infections that are caused by susceptible bacteria. Its recommended dose is 15mg/kg given by intravenous infusion once a day for four days to seven days. Full prescribing information is here.

Generic Approved for Invanz

Aurobindo Pharma Limited received FDA approval on June 25, 2018, for ertapenem injection, the generic for Invanz® (Merck). Ertapenem is an antibacterial drug that is either infused or injected intramuscularly to treat several types of complicated infections for patients as young as three months old. Aurobindo plans to launch the generic in July. According to IQVIA, the global market for Invanz was approximately $387 million for the twelve-month period that ended on April 30, 2018.

Braftovi and Mektovi Approved to Treat Melanoma

On June 27, 2018, the FDA approved Array BioPharma’s two new oncology drugs, Braftovi (encorafenib) capsules and Mektovi® (binimetinib) tablets. They are kinase inhibitors that will be used together to treat unresectable or metastatic melanoma for patients who test positive for BRAF V600E or BRAF V600K mutations. Braftovi’s recommended dose is 450mg once a day. It will be available in capsules containing 50mg or 75mg to allow for dosage adjustments if patients experience side effects. Mektovi is taken twice a day at doses of 45mg (three tablets) each. Complete prescribing information for Braftovi is here and for Mektovi is here.

Generic Advair Diskus Delayed

On June 27, 2018, the FDA sent a Complete Response Letter to Mylan concerning their application for a generic to Advair Diskus® (fluticasone propionate/salmeterol inhalation powder – GlaxoSmithKline). According to Mylan, the FDA identified “minor deficiencies” in the application. Mylan was expecting the delay and it will provide updated guidance for possible FDA approval. Mylan also noted that because the application was previously granted a priority review, it could receive approval before the standard 90-day review period that follows resubmission of a generic application. As a result, Mylan’s generic Advair Diskus still could receive FDA approval before the end of 2018.

FDA Approves Qbrexza to Treat Hyperhidrosis

On June 28, 2018, the FDA approved Dermira’s Qbrexza (glycopyrronium) cloth. It is indicated for treating patients nine years of age and older who have primary axillary hyperhidrosis (excessive underarm sweating). Dermatologists estimate that around 10 million Americans have the condition. Beginning in October, Qbrexza will be available in boxes of 30 single-use packets each containing one cloth saturated with 2.4% glycopyrronium, a drug that reduces the activity of sweat glands. Directions are to use one cloth to rub each armpit only one time, once a day. It should not be used on skin that is irritated. After disposing of the used cloth, patients are advised to wash their hands thoroughly and to avoid touching their eyes. Among its common side effects are dry mouth, blurry vision and dilated pupils that could increase light sensitivity. Full prescribing information is here.








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