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  USA Approved Drugs 2016

New Drugs 2016

Spinraza (nusinersen sodium)-Biogen

Spinraza was approved in December 2016 in children and adults for the treatment of spinal muscular atrophy (SMA) and is the first drug in the U.S. for this indication. Spinraza is a survival motor neuron (SMN2)-directed antisense oligonucleotide that targets SMN2, potentially increasing the amount of full-length SMN protein in SMA patients with SMN protein deficiency. FDA approval was based on multiple clinical studies in over 170 patients including ENDEAR, a Phase 3, randomized, double-blind, sham controlled study in infantile-onset SMA patients. The participants achieved more motor milestone responses (40% vs. 0%) and showed a lower death rate (23% vis. 43%) than the placebo group. The most common side effects were upper and lower respiratory infections and constipation. Spinraza is available as 12mg/5mL single-dose vials and is administered intrathecally.

Rubraca (rucaparib)-Clovis Oncology

Rubraca received accelerated approval in December 2016 specifically for women with advanced ovarian cancer with a deleterious BRCA mutation and who have had treatment with two or more chemotherapies. Rubraca is a poly ADP-ribose polymerase inhibitor that can increase cancer cell death by blocking the enzyme responsible for repairing the damaged DNA (from mutations in the BRCA genes) inside the cancer cells. Safety and efficacy were studied in 2 clinical trials of 106 patients. These studies showed 54% of Rubraca-treated patients to have a complete or partial shrinkage of tumors. The most common side effects were nausea, fatigue, vomiting, abdominal pain, anemia, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. Serious risks could include myelodysplastic syndrome, acute myeloid leukemia, and fetal harm. Rubraca is available as 200 mg or 300 mg tablets and the recommended dosage is 600mg taken by mouth twice daily.

Eucrisa (crisaborole)-Pfizer

Eucrisa was approved December 2016 by the FDA for treatment of mild-to-moderate atopic dermatitis in patients two years and older. Eucrisa ointment is the first non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor and is applied twice daily. Its safety and efficacy were studied in two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials in 1,522 patients with atopic dermatitis between the ages of 2-79. The study showed that patients treated with Eucrisa had a better response of clear to almost clear skin after 28 days and some patients saw improvement in as little as 8 days. The most common adverse effects were pain, burning, or stinging at the site of application. Eucrisa is a 2% ointment available in 60 and 100 gram tubes.

Soliqua (insulin glargine and lixisenatide)-Sanofi-Aventis

Soliqua was approved in November 2016 in type 2 diabetic adult patients that are not controlled on less than 60 units of basal insulin or lixisenatide. Soliqua is a once-daily, fixed-ratio combination (100/33) of insulin glargine (Lantus) and the glucagon-like peptide-1 receptor agonist lixisenatide (Adlyxin). It was studied in a Phase 3 trial of more than 1,900 patients and has shown the potential to lower HbA1c better than Lantus with similar rates of hypoglycemia. Fifty-five versus thirty percent of participants achieved the target of HbA1c less than 7% at 30 weeks. The most common side effects were hypoglycemia, nausea, nasopharyngitis, diarrhea, and upper respiratory tract infection. Soliqua uses the SoloStar technology and is available as a single pre-filled pen that can deliver 15 to 60 units of insulin glargine and 5 to 20 mcg of lixisenatide.

Xultophy (insulin degludec and liraglutide)-Novo Nordisk

Xultophy was approved in November 2016 in type 2 diabetic adults not controlled on 50 units of basal insulin daily or less than 1.8 mg of liraglutide daily. Xultophy is a fixed-ratio combination of the long-acting insulin degludec (Tresiba) and the glucagon-like peptide-1 receptor agonist liraglutide (Victoza). Xultophy was studied in the DUAL clinical development program in 3 trials of 1,393 adults with type 2 diabetes not controlled on liraglutide or basal insulin. The switch to Xultophy showed reductions in HbA1c and for those uncontrolled on basal insulin, there was a reduction of HbA1c from baseline of 1.67% and 1.94%. The most common side effects observed were nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection. Xultophy is available as a prefilled pen to deliver a once-daily injection. The dosage ranges from 16 units (16 units of insulin degludec and 0.58 units of liraglutide) to a maximum of 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).

Intrarosa (prasterone)-Endoceutics

Intrarosa was approved in November 2016 for moderate to dyspareunia caused by vulvar and vaginal atrophy in postmenopausal women. Intrarosa is the first FDA approved medication with dehydroepiandrosterone (DHEA) or prasterone and is a once-daily vaginal insert. The efficacy was studied in two placebo-controlled, randomized trials of 406 postmenopausal women ages 40 to 80 for 12 weeks. Study participants experienced moderate to severe pain during intercourse and were randomized to Intrarosa or placebo. Intrarosa was shown to reduce the severity of intercourse related pain compared to the placebo group. The most common side effects of vaginal discharge and abnormal Pap smear were seen during four 12-week placebo-controlled trials and one 52-week open-label trial. Intrarosa is available in boxes of 4 blister packs each with 7 vaginal inserts with 28 applicators.

Tecentriq (atezolizumab)

Tecentriq was granted an accelerated approval by the FDA in May 2016. The accelerated approval program is a conditional approval based on early data suggesting clinical benefit for a serious condition with an unmet need. In this case, Tecentriq is approved for patients with locally advanced or metastatic urothelial carcinoma who have progressed on platinum-based chemotherapy. This approval was based on tumor response rate and duration of response in the IMvigor 210 study, an open-label, multicenter, two-cohort Phase II study in patients with locally advanced or metastatic urothelial carcinoma without regard to PD-L1 expression. Tecentriq is an Fc-engineered, humanized, monoclonal antibody that works by binding to the protein PD-L1 on tumor cells blocking interactions with the PD-1 and B7.1 receptors. Tecentriq is an injection for intravenous infusion and is available as a single-dose vial with 1200 mg/20 mL. The solution should be stored under refrigeration. The most common adverse reactions were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. Serious events included immune-related pneumonitis, hepatitis, colitis, endocrinopathies, infections, infusion reactions, and embryo-fetal toxicity. The estimated cost of therapy is about $12,500 per month.

Kovaltry (Antihemophilic Factor Recombinant)-Bayer

Kovaltry (Antihemophilic Factor Recombinant)-Bayer - was approved in March 2016 in children and adults for the treatment of hemophilia A (Factor VIII deficiency) by replacing the missing clotting Factor VIII. Kovaltry can be used for the treatment and control of bleeding, perioperative bleeding, and for prophylaxis to decrease bleeding episodes. Kovaltry was studied in a series of multi-centered, uncontrolled clinical trials called the LEOPOLD TRIALS (1,2, and Kids Part A). Some of the results included a 93.3% reduction in bleeding rates in patients taking Kovaltry twice a week prophylactically and a 96.7% reduction rate in those taking it three times a week. The most common adverse effects were headache, pyrexia, and pruritus. Kovaltry is available as a powder for solution to be reconstituted and used intravenously. Dosing varies with patient weight, age, and indication.

Idelvion (Coagulation Factor IX Recombinant, albumin fusion protein)- CSL Behring

Idelvion (Coagulation Factor IX Recombinant, albumin fusion protein)- CSL Behring - was approved in March 2016 in adults and children with Hemophilia B (congenital Factor IX deficiency) to control and prevent bleeding episodes, manage perioperative bleeding, and as routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Idelvion, the first to link Factor IX to albumin, replaces the missing or defective clotting Factor IX in patients with Hemophilia B. Idelvion was studied in 2 multicenter studies of 90 adult and pediatric patients with Hemophilia B. Idelvion was found to be effective in controlling bleeding episodes and managing perioperative bleeding. Used prophylactically, it significantly reduced the rate of spontaneous bleeding episodes per year even though the infusions were given less frequently. Hypersensitivity reactions and thromboembolism can occur but the most common adverse reaction reported during clinical trials was headache. Idelvion is available in single-use vials of lyophilized powder (250IU, 500 IU, 1000 IU, or 2000 IU) requiring reconstitution with sterile water for injection.

Defitelio (defibrotide sodium)- Jazz Pharmaceuticals

Defitelio (defibrotide sodium)- Jazz Pharmaceuticals- was approved in March 2016 as the first FDA approved treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction, a rare but often fatal complication of hematopoietic stem cell transplantation (HSCT). Defitelio is a deoxyribonucleic acid derivative anticoagulant derived from porcine mucosal DNA. Along with its antithrombotic activity, the drug has also shown anti-inflammatory and antiischemic activities in recent studies. Defitelio is supplied as an IV solution given 6.25 mg/kg (over a 2 hour infusion) every 6 hours for a minimum of 21 days and continued until resolution of symptoms. Approval was based on 3 studies in 528 patients with hepatic VOD with renal or pulmonary dysfunction following HSCT. Overall survival was measured after 100 days. Thirty-eight to forty-five percent of patients treated with Defitelio survived 100 days after HSCT versus expected survival rates of 21-31% with other interventions or supportive care. The most common side effects reported were hypotension, diarrhea, vomiting, nausea and nose bleeds. Serious side effects included hemorrhage and allergic reactions. The price per patient per course of treatment will vary based on the weight of the patient and the duration of treatment but the wholesale acquisition cost is estimated to be $825 per 200mg/2.5 ml vial.

Venclexta (venetoclax)- Abbvie

Venclexta (venetoclax)- Abbvie- was approved April 2016 as the first FDA-approved therapy that targets the B-cell lymphoma 2 (BCL-2) protein for treatment of chronic lymphocytic leukemia adult patients with the 17p deletion chromosomal abnormality. The BCL-2 protein can be overexpressed in CLL patients resulting in cancer cell growth. Patients treated with Venclexta should have been treated with at least one therapy prior to Venclexta treatment and a 17p deletion should first be confirmed. Venclexta is available as 10mg, 50mg, and 100mg tablets and is titrated up over 5 weeks from 20mg to a target dose of 400mg per day. Efficacy of this Venclexta dosage was studied in a single-arm clinical trial of 106 patients with CLL and 17p deletion. In this trial, 80% of patients saw a complete or partial remission. Common side effects of Venclexta are neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue. Serious adverse events include pneumonia, febrile neutropenia, fever, autoimmune hemolytic anemia, and tumor lysis syndrome. The estimated cost for the first year of treatment is $109,500.

Taltz (ixekizumab) Eli Lilly

Taltz (ixekizumab) - was approved in March 2016 for the treatment of moderate to severe plaque psoriasis specifically in adults who are candidates for systemic therapy. Taltz is a humanized IgG4 monoclonal antibody that works by targeting the interleukin 17A cytokine. This binding inhibits its interaction with the IL-17 receptor and the release of proinflammatory cytokines and chemokines. Taltz is available as an 80 mg subcutaneous injection and is dosed as 160 mg at Week 0, 80 mg at Weeks 2,4,6,8,10 and 12, then 80 mg every 4 weeks. Taltz was studied in 3 double-blind, multicenter studies in 3,800 subjects. These studies, UNCOVER-1, UNCOVER-2 and UNCOVER-3, evaluated the safety and efficacy of Taltz versus placebo for 12 weeks. In patients treated with Taltz, 87-90 percent saw a significant improvement of psoriasis plaques, 68-71 percent saw virtually clear skin, and 35-42 percent saw complete resolution of psoriasis plaques (all measured by psoriasis area severity index scores or PASI). These responses were maintained in 75 percent of patients at the 60 week endpoint. Taltz was also compared to etanercept 50 mg twice a week in UNCOVER-2 AND UNCOVER-3 and was shown to be superior in all skin clearance levels (87% vs. 41% for PASI 75). Side effects associated with Taltz were injection site reactions, upper respiratory infections, nausea, and tinea infections.

Odefsey (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) Gilead Sciences

Odefsey (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) -Gilead Sciences- was approved in March 2016 and is indicated as a complete regimen for the treatment of HIV-1 in patients 12 years and older as initial therapy in patients with no antiretroviral history and RNA less than or equal to 100,000 copies per mL. It may also replace stable regimens in those virologically suppressed with RNA less than 50 copies per mL for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. Odefsey contains two nucleoside analog reverse transcriptase inhibitors (emtricitabine and tenofovir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine). Available as a tablet formulation, the drug is dosed one tablet once daily with a meal. Some possible side effects include depressive disorders, insomnia, headache, and nausea. There is a black box warning for possible lactic acidosis and severe hepatomegaly with steatosis. Severe exacerbations of Hepatitis B have been reported in patients with HIV and HBV that have discontinued products with emtricitabine and tenofovir.

Cinqair (reslizumab) Teva Pharmaceuticals

Cinqair (reslizumab)-Teva Pharmaceuticals- was approved in March 2016 for adults 18 and older as an add-on maintenance treatment in patients with severe asthma with eosinophilic phenotype. Cinqair is a monoclonal antibody and an interleukin-5 antagonist that inhibits IL-5 and lowers eosinophils in the blood. The drug is available as an intravenous solution and is given 3 mg/kg over 20-50 minutes once every 4 weeks. The drug received approval based on 4 double-blind, randomized, placebo-controlled trials in over 1000 patients with severe asthma not controlled with available therapies. They received Cinqair as an add on or placebo every 4 weeks. Asthma exacerbations in the Cinqair group were reduced by 59% versus placebo. Side effects included oropharyngeal pain, muscle pain, cancer, and potentially life-threatening anaphylaxis (black box warning).

Briviact (brivaracetam)UCB

Briviact (brivaracetam)-UCB- was approved in February 2016 as adjunctive therapy in the treatment of partial-onset seizures in epileptic patients 16 and older. Although the exact mechanism is unknown, Briviact shows selective affinity for synaptic vesicle protein 2A in the brain. Briviact is available as tablet, oral solution, or intravenous injection. The recommended starting dosage is 50 mg twice daily but can be titrated up to 100 mg twice daily or down to 25 mg twice daily, based on individual responses. Briviact was studied in 1550 patients with partial-onset seizures not controlled by 1-2 antiepileptic drugs. The three phase III trials were randomized, double-blind, placebo-controlled, multicenter studies that required at least 8 partial-onset seizures in a 8 week baseline period. Briviact showed statistically significant reductions over placebo in frequency of partial-onset seizures per 28 days (19.5% for 50 mg/day, 24.4% for 100 mg/day, and 24.0% for 200 mg/day, p<0.01). Also, 34.2% (50 mg/day), 39.5% (100 mg/day), and 37.8% (200 mg/day) versus 20.3% (placebo) of patients showed a 50% or greater reduction in partial-onset seizure frequency. Side effects included somnolence/sedation, dizziness, fatigue, nausea, and vomiting.

Onzetra Xsail (sumatriptan) Avanir

Onzetra Xsail (sumatriptan) -Avanir- was approved in January 2016 and is a nasal powder formulation of sumatriptan delivered by the Xsail breath-powered delivery device. Onzetra Xsail, a serotonin 5-HT1B/1D receptor agonist, is indicated in adults for the acute treatment of migraine with or without aura. The recommended dose is 22mg (11 mg in each nostril) which can be repeated in at least 2 hours with a maximum dose of 44mg in a 24 hour period. Onzetra Xsail was studied in a multicenter, randomized, double-blind, placebo-controlled study in those with moderate to severe migraine headache. The percent of patients that achieved headache relief 2 hours after treatment was 68% in the Onzetra Xsail group versus 45% in the placebo group. The most common side effects were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

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