New Drug Approvals March – June 2016

Name Manufacturer Indication Date Approved Average Wholesale Price
Odefsey
(emtricitabine, rilpivirine and tenofovir alafenamide)
Gilead Sciences, Inc. HIV March 1, 2016 $2,815 per 30 days
Kovaltry
(antihemophilic factor)
Bayer Healt

hCare Pharmaceuticals, Inc.

Hemophilia A March 17, 2016 $61.20 per 30 days
Cinqair
(reslizumab)
Teva Pharmaceuticals USA, Inc. Severe Asthma March 23, 2016 $3,006 per 30 days
Descovy
(emtricitabine and tenofovir alafenamide)
Gilead Sciences, Inc. HIV April 4, 2016 $1,759.73 per 30 days
Inflectra
(infliximab-dyyb)
Celltrion, Inc. Rheumatoid Arthritis, Ulcerative Colitis, Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Crohn’s Disease April 5, 2016 Not available at the current time.
Bevespi Aerosphere
(formoterol fumarate and glycopyrrolate)
AstraZeneca Pharmaceuticals LP COPD April 25, 2016 Not available at the current time.
Xtampza ER
(oxycodone)
Collegium Pharm, Inc. Pain Management April 26, 2016 Not available at the current time.
Fycompa
(perampanel)
EISAI, Inc. Partial-Onset Seizures April 29, 2016 $405
(2 mg/day) – $1,620
(8 mg/day) per 30 days
Nuplazid

(pimavanserin)

Acadia Pharmaceuticals, Inc. Parkinson’s Disease Psychosis April 29, 2016 $1,170 per 30 days
Jentadueto XR

(linagliptin and metformin)

Boehringer Ingelheim Type II Diabetes May 31, 2016 2.5 mg/
1000 mg
$359
Byvalson

(nebivolol and valsartan)

Forest Laboratories, Inc. Hypertension June 3, 2016 Not available at the current time.
Gonitro
(nitroglycerin)
Espero Pharmaceuticals, Inc. Angina Pectoris June 14, 2016 Not available at the current time.
Glassia
(alpha1-proteinase inhibitor)
Kamada Ltd. Alpha1-Antitrypsin
Deficiency
(AAT)
June 15, 2016 1 g/50 mL
$29,736

 

Odefsey – A new once a day fixed dose combination tablet of emtricitabine 200mg, ripivirine 25 mg, and tenofovir 25mg.  It is indicated for the treatment of HIV – 1 infection in patients 12 years of age and older as a complete therapy in those who have no history of antiretroviral therapy and HIV-1 RNA level less than or equal 100 copies per ml; or to replace a stable antiretroviral regimen in those who are virologically – suppressed (HIV-1 RNA less than 50 copies per ml) for at least 6 month with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. This is Gilead’s second FDA approved TAF-based regimen and represents the smallest pill of any single tablet regimen for the treatment of HIV.

Kovaltry – A new drug for the treatment and control of bleeding episodes in adults and children with hemophilia. It is caused from insufficient clotting Factor VIII activity, which is a protein in the blood that controls bleeding. Usually patients with this condition experience bleeding episodes that cause pain, irreversible joint damage, and life‐threatening hemorrhages. Kovaltry is a full length Factor VIII concentrate, recommended to be used through intravenous infusions, to prevent bleeds as well as to manage bleeding episodes and to control bleeding associated with surgical or dental procedures. Available dosage forms for Kovaltry include single‐use vials containing 250 international units (IUs), 500 IUs, 1,000 IUs, 2,000 IUs, or 3,000 IUs of powdered Kovaltry. The dosing and dose frequency for the drug is dependent on the patient’s age, weight, and on whether the dose is for prevention or for treating an acute bleed. Most patients however may require infusions 2 to 3 times per week for routine prophylaxis.

Cinqair – An add‐on maintenance treatment for patients 18 years of age and older with severe asthma with an eosinophilic phenotype. The submitted data did not show consistent efficacy in patients 12 to 17 years of age. The bases of its approval was clinical studies that showed it reduced asthma exacerbations by up to 59% compared to placebo. Due to the undesired effects of systemic corticosteroids, the aim of this is to utilize the lowest effective dose or avoid use of systemic corticosteroids, when possible. The major safety finding of note was anaphylaxis, which could be managed given that the product will be administered in health care facility because of IV dosing, and with close health care provider supervision. The recommended dose for Cinqair is 3mg/kg via intravenous infusion (IV) every 4 weeks. Dosage forms available include 100mg/10mL injectable solution in single‐use vials.

Descovy– A two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF) for treatment of HIV-1 infection in patients 12 years of age and older. The recommended dosage is one tablet taken daily with or without food.  Descovy is similar to two other Gilead products, Viread and Genvoya, however it includes lower dosage of tenofovir alafenamide.  Tenofovir alafenamide is effective in smaller doses reducing the risk of causing kidney damage and bone marrow density issues.

Inflectra – Biosimilar to Janssen’s Remicade and is indicated for treating patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease. While Inflectra is biosimilar to Remicade, it is not considered a generic medication and cannot be considered interchangeable with Remicade without approval from a physician. The dose of Inflectra varies depending on the indication.

Bevespi Aerosphere – Indicated for use as maintenance treatment for chronic obstructive pulmonary disease (COPD) and provides a combination of a long‐acting muscarinic antagonist (LAMA) and a long‐acting beta‐2 agonist (LABA). The recommended dose is two oral inhalations in the morning and two in the evening, each dose containing 9 micrograms (mcg) of glycopyrrolate and 4.8 mcg of formoterol fumarate. Bevespi Aerosphere contains 120 inhalations per canister.

Xtampza ER – An opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The daily dosage is limited to a maximum of 288 mg per day. The drug uses a new method to significantly reduce both the potential for abuse and the risk of overdosing. This new method mixes wax and fatty acids to form microspheres, that each contain active drug ingredients. The wax keeps the opioid from being dissolved and injected, and it also prevents rapid release of the oxycodone if the capsules are mashed. Xtampza ER is offered in time released capsules of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), or 36 mg (equivalent to 40 mg oxycodone HCl).

Fycompa – Approved for the treatment of partial‐onset seizures with or without secondarily generalized seizures, and primary generalized tonic‐clonic seizures in patients with epilepsy 12 years of age and older. Starting dose is 2 mg once daily at bedtime in patients not on enzyme-inducing anti-epileptic drugs and 4 mg in patients on enzyme-inducing AEDs. The recommended starting dosage of Fycompa in the presence of enzyme-inducing AEDs, including phenytoin, carbamazepine, and oxcarbazepine, is 4 mg and patients should be monitored closely for response. Clinical trials revealed a substantially reduced effect on seizure rates in these patients. The reduction in seizure frequency was somewhat greater at 12 mg than at 8 mg.

Jentadueto XR – Approved for use in adult patients with type II diabetes where treatment with both linagliptin and extended‐release metformin is appropriate. It is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. The product is a once‐daily fixed dose combination. Jentadueto XR is available in two strengths (linagliptin/metformin ER) 5 mg/1000 mg and 2.5 mg/1000 mg. The total daily dose shouldn’t exceed linagliptin 5 mg and metformin 2000 mg.

Byvalson – A new once a day anti-hypertensive combination product. It contains 5 mg of a beta blocker (nebivolol) and 80 mg of valsartan, an angiotensin II receptor blocker (ARB). Byvalson can be used either as first‐line treatment or for patients whose high blood pressure is not managed adequately by taking either nebivolol or valsartan alone. It also may be taken with drugs from other classes, such as diuretics. Maximum antihypertensive effects are attained within 2 to 4 weeks of therapy.

Gonitro – A nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. It will be available in packets, each containing 400 micrograms (mcg) of nitroglycerin. The recommended dose is one or two packets under the tongue at the onset of an angina attack. One additional packet can be administered every 5 minutes as needed, not to exceed three packets within a 15 minute period. Gonitro can also be used to prevent chest pain prior to engaging in activities that could provoke an acute angina attack.

Glassia – Originally approved in 2010 for the treatment of alpha1‐antitrypsin (AAT) deficiency, have been approved for self-infusion at home after appropriate training. AAT deficiency is a chronic, genetic disorder that can lead to the destruction of lung tissue, Glassia is an alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency. The recommended dose of Glassia is 60 mg/kg administered by intravenous infusion once weekly.

 

New Specialty Drug Approvals March – June 2016

Name Manufacturer Indication Date Approved Average Wholesale Price
Taltz
(ixekizumab)
Eli Lilly and Company Plaque Psoriasis March 22, 2016 $4,924 per syringe
Venclexta
(venetoclax)
AbbVie, Inc. Chronic Lymphocytic Leukemia April 11, 2016 Not available at the current time.
Lenvima
(lenvatinib)
Eisai, Inc. Renal Cell Carcinoma May 13, 2016 Not available at the current time.
Zinbryta
(daclizumab)
AbbVie, Inc. and Biogen Multiple Sclerosis May 27, 2016 Not available at the current time.

 

Taltz – Humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is administered by subcutaneous injection. The recommended dose is two 80 mg injections at Week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. Patients may self-inject after training in subcutaneous injection technique using the auto-injector or prefilled syringe.

Venclexta – Second‐line treatment of patients with Chronic Lymphocytic Leukemia (CLL) with 17p deletion, which is detected by an FDA approved test. Venclexta is also indicated for use in combination with Rituxan (rituximab) with a breakthrough therapy designation for the treatment of relapsed or refractory CLL and for the first‐line treatment of acute myeloid leukemia (AML) with hypomethylating agents in patients who are not candidates to receive standard high‐dose chemotherapy. FDA approval is based on a clinical trial that showed that 80 percent of patients treated with Venclexta had a complete or partial response to therapy. The suggested starting dose is 20 mg once daily for seven days and should be titrated weekly to the recommended dose of 400 mg once daily. Venclexta is available in 10 mg, 50 mg, and 100 mg tablets. Venclexta is the first B‐cell lymphoma 2 (BCL‐2) inhibitor to gain FDA approval.

Lenvima – A kinase inhibitor that is indicated for Differentiated Thyroid Cancer (DTC): single agent for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC and Renal Cell Carcinoma (RCC), in combination with everolimus, for patients with advanced RCC following one prior anti-angiogenic therapy. The recommended daily dose of Lenvima is 24 mg (two 10 mg capsules and one 4 mg capsule) orally taken once daily.

Zinbryta – An interleukin-2 receptor blocking antibody indicated for the treatment of adult patients with relapsing forms of Multiple Sclerosis (MS). Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. The recommended dosage is 150 mg once monthly injection.

 

New Generic Drug Launches March – June 2016

Generic Brand Name Manufacturer Indication Date Launched
oxiconazole Oxistat Taro Fungal infection March 11, 2016
frovatriptan succinate tablet Frova Glenmark Pharms Ltd. Migraine March 13, 2016
diclofenac gel Voltaren Gel Amneal Pharmaceutical Osteoarthritis March 18, 2016
mometasone furoate monohydrate Nasonex Apotex Allergic rhinitis March 22, 2016
rosuvastatin Crestor Watson Labs, Inc. Hypercholesterolemia April 28, 2016
doxycycline Doryx Mylan Bacterial Infection June 1, 2016
dofetilide Tikosyn Pfizer Atrial fibrillation/
Atrial flutter
June 7, 2016

 

oxiconazole – Indicated for the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) and tinea versicolor (generalized rash or discolored patches), that are caused by specific types of fungus. Oxiconazole cream 1% is the first generic alternative to Fougera Pharmaceutical’s Oxistat, a topical antifungal drug, applied to affected areas once or twice a day.

frovatriptan succinate tablet – Indicated for the treatment of migraine headaches, and to prevent menstruation‐associated migraines. This is a generic for Endo Pharmaceutical’s brand name Frova. The recommended dose is one tablet to be taken at the beginning of the migraine pain, and if needed, a second tablet could be taken after two hours with no more than three tablets used in 24 hours. For menstruation‐associated migraines, it is recommended that Frova be taken regularly for six days before the period starts.

diclofenac gel – A topical non‐steroidal anti‐inflammatory drug (NSAID) for the treatment of Osteoarthritis in affected joints. Diclofenac gel is the first generic for Endo Pharmaceutical’s Voltaren gel. The gel will be dispensed in cards that measure doses into 2 or 4 gram units. The 2 gram units will be used for fingers, hands, wrist, and elbow joints, while the 4 gram units will be used for foot, ankle, and knee joints. The recommended dosage for use is four times a day with a total daily dosage of no more than 32 grams. Diclofenac gel is available in 100 gram tubes.

mometasone furoate monohydrate – A corticosteroid primarily used for the treatment of nasal symptoms associated with allergic rhinitis. This is a generic version of Merck’s Nasonex. Dosage forms available for the newly launched generic include 50 mcg of mometasone furoate monohydrate in each 100 microliter nasal spray. Although nasal corticosteroids are in the process of transitioning from prescription to over‐the‐counter, plans and timing for Nasonex to convert from a prescription to an over‐the‐counter drug are currently unknown. Other nasal corticosteroids including Flonase, Nasacort, and Rhinocort Aqua are already in the approval process.

rosuvastatin – Generic version of Actavis’s Crestor that is indicated for use in combination with diet for treatment of high triglycerides (hypertriglyceridemia) in adults and for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides. It is also indicated either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low‐density lipoprotein (LDL) cholesterol. The most common side effects include headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea.

doxycycline – Mylan launched its A‐rated generic alternative to Mayne Pharma’s Doryx (doxycycline hyclate delayed‐release) 50 mg tablets. Doryx is a tetracycline antibiotic that is used for a variety of conditions including acne, respiratory tract infections and sexually transmitted infections.

dofetilide – A generic alternative to Pfizer’s Tikosyn (dofetilide), which is available in 125 micrograms (mcg), 250 mcg and 500 mcg capsules. Tikosyn is an antiarrhythmic agent used to prevent irregular heartbeats, including atrial fibrillation and atrial flutter.

 

For an impact analysis, contact your EmpiRx Health Account Executive at 201-746-6901.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178

*This is provided for informational purposes only. Reference to any medication above does not mean the medication is covered by your plan.

 


Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivity, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

Drug News: FDA Approvals & Generic Launches June – August 2016
FDA has approved Epclusa – New treatment for Chronic Hepatitis C