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Drug Update: December 2017

Specialty Drug Approvals

New Gene Therapy Approved for Rare Vision-Threatening Condition: Luxturna®

In December 2017, the U.S. Food and Drug Administration (FDA) approved the first gene therapy for treating patients with disease caused by a specific genetic mutation. Luxturna® (voretigene neparvovec-rzyl) is approved to treat children and adults with a rare, inherited condition causing loss of vision. It is indicated specifically for patients with retinal dystrophy caused by a RPE65 mutation in both copies of the gene. These mutations can lead to loss of vision and result in blindness in some individuals. Luxturna is administered as a one-time injection into each eye by an experienced eye surgeon.

An estimated 1,000 to 2,000 individuals in U.S. are affected with RPE65 mutation-associated retinal dystrophy in both forms of the gene (biallelic mutation). The RPE65 gene is responsible for the development of an enzyme used in the process of vision, and mutations in this gene lead to impaired vision. As time progresses, patients with these mutations can experience a decline in their vision which can result in complete blindness. As a gene therapy, Luxturna delivers a normal copy of the RPE65 gene to the cells of the retina resulting in production of a normal enzyme and restoration of vision. It is estimated there are more than 900 gene therapies currently under development and experts have speculated approximately 40 gene therapies may receive FDA approval by 2022.

A Phase III study conducted in 31 patients found patients who received Luxturna exhibited significant improvement in the ability to complete an obstacle course at low levels of light compared to the control group. The most common side effects of Luxturna include eye redness, cataracts, increased eye pressure, and tearing of the retina. An additional study will be performed to evaluate the long-term safety of the new gene therapy. Luxturna is expected to be available in select treatment centers starting in 2018. For additional information on the FDA-approval of the first gene therapy for a specific mutation, please view the FDA’s press release.


New Formulation of Enbrel® FDA-Approved and Commercially Available: Enbrel Mini™ with AutoTouch™

A new delivery system and formulation of Enbrel® (etanercept) has received FDA-approval. The new AutoTouch™ device was designed to help reduce pain at the injection site and is used with the new Enbrel Mini™ single-dose prefilled 50 mg/mL cartridges. The AutoTouch delivery system has an ergonomic handle, a hidden needle, and a sensor that detects the device is in contact with skin as well as a progress bar, speaker, and three injection speeds. The new device and formulation were approved in September 2017 following Phase III trials in adults demonstrating a significant reduction in injection-site pain compared to the other Enbrel injection formulations.

Enbrel is FDA-approved to treat chronic inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis. It was first approved in 1998 for moderate-to-severe rheumatoid arthritis. NPS is planning to review the new formulation and device for placement on the national formularies. For additional information on the new Enbrel Mini with AutoTouch formulation, please view the manufacturer’s press release.


New Drug Approval

FDA Approves New Topical Eye Solution for Glaucoma: Vyzulta®

Vyzulta® (latanoprostene bunod) ophthalmic 0.024% solution has been FDA-approved for reducing eye pressure in patients with open-angle glaucoma or ocular hypertension. Glaucoma is a disease characterized by damage to the trabecular meshwork in the eye leading to decreased drainage and higher intraocular pressure (IOP) / fluid eye pressure. Vyzulta works in two ways to reduce IOP. It increases drainage from the eye and also releases nitric oxide (NO) to open up the trabecular meshwork increasing fluid outflow. Vyzulta is unique as it provides the first prostaglandin analog that releases nitric oxide. Studies have demonstrated that nitric oxide is involved in controlling the IOP in normal eyes, and patients with glaucoma have decreased levels of nitric oxide. As a result, products releasing NO may be beneficial for patients with open-angle glaucoma or ocular hypertension.

The safety and efficacy of Vyzulta were evaluated in the APOLLO and LUNAR Phase III, randomized, double-masked, and parallel-group studies. These trials compared Vyzulta with timolol maleate ophthalmic solution 0.5% in more than 800 patients with open-angle glaucoma or ocular hypertension. The studies evaluated whether Vyzulta once daily was non-inferior and superior to timolol twice daily in the mean IOP reduction over 3 months. Vyzulta was found to be non-inferior to timolol and demonstrated significantly greater IOP lowering throughout the day at 3 months of treatment. The most common eye-related adverse events included eye redness (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). Increases in the pigmentation of the iris and eyelid as well as growth of eye lashes may also occur.

For adults and adolescents (17 years and older) the dosage of Vyzulta is one drop applied to the affected eye once every evening. The maximum dosage is one drop/day per affected eye. NPS is planning to review Vyzulta for placement on the national formularies. For more information, please view the manufacturer’s press release.


New Indication

Taltz® Approved for the Treatment of Psoriatic Arthritis

Taltz® (ixekizumab) received FDA-approval earlier this month for the treatment of adults with active psoriatic arthritis (PsA). It was already approved for the treatment of adults patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. PsA is a form of arthritis that has an inflammatory component and affects approximately 1.6 million Americans. It usually affects joints in the arms and legs, such as the elbows, wrists, hands, and feet. Untreated PsA could lead to irreversible joint damage. It is estimated that PsA occurs in 10% to 20% of individuals with psoriasis. As it has similar symptoms to other forms of arthritis, the Centers for Disease Control and Prevention (CDC) recommends it be diagnosed by a rheumatologist.

Approval of Taltz for the treatment of PsA was based on two Phase III studies: SPIRIT-P1 and SPIRIT-P2. SPIRIT-P1 compared the safety and efficacy of Taltz to placebo in PsA patients who had not previously received treatment with any biologic disease-modifying anti-rheumatic drug (DMARD). SPIRIT-P2 compared the safety and efficacy of Taltz to placebo in PsA patients who had failed one or two tumor necrosis factor (TNF) inhibitors. The primary endpoint in both studies was the percentage of patients achieving ACR20 which is a measure of disease activity defined by the American College of Rheumatology. At 24 weeks, 58% of patients in the SPIRIT-P1 trial who had received Taltz achieved ACR20 compared to 30% of patients who received placebo. In the SPIRIT-P2 trial, 53% of patients who received Taltz achieved ACR20 compared to 20% of patients on placebo.

Notable warnings and precautions for Taltz include the risk for infections and tuberculosis. Patients should contact their physician if signs or symptoms of an infection develop. Patients who will be receiving Taltz should complete all recommended age-appropriate vaccines prior to therapy initiation and should not receive live vaccines during therapy. Taltz should be temporarily withheld if a serious infection occurs and discontinued if a serious allergic reaction occurs. Inflammatory bowel disease (IBD) and episodes of worsening IBD have occurred during clinical trials. Patients with IBD should be monitored closely. Common side effects of Taltz include injection site reactions, upper respiratory tract infections, nausea, and ear infections. 

The recommended dosage for PsA is 160 mg given by subcutaneous injection at week 0, then 80 mg every 4 weeks thereafter. Patients with both PsA and moderate-to-severe plaque psoriasis should use the dosing regimen for plaque psoriasis. Taltz can be used alone or with traditional treatments, such as methotrexate. Taltz is currently a specialty medication on the NPS national formulary and carries an average wholesale price (AWP) of $5,732.82 per each 80 mg dose.


Generic Approvals

Generic Tamiflu® (oseltamivir phosphate) Suspension Now Available

In September 2017, the U.S. Food & Drug Administration (FDA) approved a generic version of Tamiflu® oral suspension: oseltamivir phosphate 6 mg/mL suspension. The FDA considers approval of first-time generics to be a priority and to help improve the affordability of treatment options. Oseltamivir phosphate suspension became commercially available in November 2017.

Oseltamivir phosphate is an antiviral indicated for the treatment and prevention of influenza A and B. It is not a substitution for annual influenza vaccination. The dosing regimen is dependent on whether oseltamivir is used for the prevention or treatment of influenza and other patient-specific factors including the patient’s age and kidney function. The most common adverse effects occurring with oseltamivir are nausea, vomiting, and headache.

The oral suspension is supplied in bottles containing 360 mg of powder for reconstitution that will result in a final concentration of 6 mg/mL. The suspension is the preferred form of oseltamivir for patients who cannot swallow the oseltamivir capsules. The brand-name Tamiflu suspension carries an average wholesale price (AWP) of $3.03 per mL. There are currently two manufacturers of the generic product which carries an AWP of $2.73 per mL.


Generic Viagra® (sildenafil citrate) Now Available

Earlier this month, the erectile dysfunction drug Viagra® (sildenafil citrate) became commercially available as a generic. Although Viagra’s patents do not expire until 2020, the manufacturer of the brand-name product, Pfizer, made a settlement with generic manufacturer Teva in December 2012 allowing a launch of the generic version in December 2017. The brand-name product was initially approved in the U.S. in 1998 and is available in three tablet strengths: 25 mg, 50 mg, and 100 mg. It is taken as needed, 30 minutes to 4 hours before sexual activity. Depending on patient-specific factors, the dose may be increased to 100 mg or decreased to 25 mg. Viagra is contraindicated in patients taking nitrates, such as isosorbide dinitrate (Isordil Titradose®, Dilatrate-SR®), isosorbide mononitrate (Imdur®), nitroglycerin (Nitrostat®), or the pulmonary hypertension drug Adempas® (riociguat) due to the potential for additive blood pressure lowering effects.

Currently, there are two generic versions of the tablets with an average wholesale price (AWP) of $66.46 per tablet. In contrast, brand-name Viagra carries an AWP of $73.85 per tablet. Additional generic versions are expected to become commercially available in six months and further reduce the price of generic versions. NPS is planning to review the generic versions of Viagra for placement on the national formularies.


FDA Safety Update

Drug Recall: Riomet® Contaminated with Scopulariopsis brevicaulis

On November 27, 2017, Sun Pharmaceutical Industries Inc. voluntarily recalled two lots of Riomet® (metformin HCl oral solution) due to fungal contamination. The Class II recall was due to the presence of Scopulariopsis brevicaulis identified during Antimicrobial Preservative Effectiveness Testing (AMPET). The specific packages affected were:

10631-0206-01A160031AJanuary 2018
10631-0206-02A160031BJanuary 2018

Riomet (metformin HCl) is an oral solution used in the treatment of type 2 diabetes in adults and children ages 10 years and older. Introduction of S. brevicaulis to the respiratory system may result in the development of pneumonia, sinus infections, or wide-spread infections. Patients with a weakened immune system are particularly at risk. At the time of the recall, no adverse events had been reported related to the product contamination.

The FDA advises patients who have been dispensed affected lots to stop using the medication and return the product to place of purchase, discard, and/or contact their healthcare provider. Consumers may contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984, Monday through Friday 8:00 am to 5:00 pm Eastern Standard Time or via email at drug.safetyUSA@sunpharma.com with questions. Additionally, any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088.

NPS has notified potentially affected members and their healthcare providers of the recall by mail. The complete FDA MedWatch Recall Notice can be accessed on the FDA website.


MedWatch Report: FDA Removes Boxed Warning from Select Asthma Drugs

The FDA has removed the Boxed Warning regarding asthma-related deaths from the labels of combination inhalers that contain an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA). In 2011, the FDA mandated drug manufacturers of fixed-dose ICS / LABA products conduct large-scale studies to assess the risk of serious asthma-related events with ICS / LABA products compared to ICS alone. Following a review of the results from these trials, evaluating more than 40,000 patients, the FDA has concluded the combination does not significantly increase the risk of serious asthma-related events compared to an ICS alone. On December 20, 2017, the FDA released a Drug Safety Communication indicating the Boxed Warnings on these products would be removed based on these study findings.

ICS / LABA combination drugs are indicated for the treatment of both asthma and chronic obstructive pulmonary disease (COPD). The combination therapy improves the ability to breathe by reducing inflammation in the lungs (inhaled corticosteroid) and relaxing the muscles of the airways (long-acting beta agonist). ICS / LABA combination drugs include the following: Advair Diskus® (fluticasone / salmeterol), Advair HFA® (fluticasone / salmeterol), Airduo Respiclick® (fluticasone / salmeterol), Breo Ellipta® (fluticasone / vilanterol), Dulera® (mometasone / formoterol), and Symbicort® (budesonide / formoterol).

The large-scale studies also determined that the ICS / LABA combination treatment was more effective than an ICS alone in decreasing asthma exacerbations. Information from these studies will be included in the labels of ICS / LABA combination products in the Clinical Studies and Warnings/Precautions sections. The Boxed Warning will remain on medications that contain only LABAs, as these drugs increase the risk of asthma-related death when used without an ICS for asthma treatment. Single-drug LABA medications are indicated for the treatment of asthma, COPD, and exercise-induced asthma.

The FDA advises health care professionals to refer to the most recently approved drug labels for the respective ICS / LABA combination product for more information. Patients are advised not to discontinue their asthma medication without first discussing it with their health care provider. Patients and parents or caregivers should discuss questions or concerns with health care professionals. For additional details, please visit the FDA website.


Biosimilar Update

Ogivri® Receives FDA-Approval as First Biosimilar to Cancer Drug Herceptin®

In December 2017, the FDA approved Ogivri® (trastuzumab-dkst) as the first biosimilar to cancer drug Herceptin® (trastuzumab). The new product was developed from a partnership between Mylan and Biocon and is indicated for the treatment of HER2+ breast cancers and metastatic stomach cancers. In 2017, there will be an estimated 250,000 and 28,000 new cases of female breast cancer and stomach cancers diagnosed in the U.S, respectively. It is estimated that up to 25% of these breast cancer cases express the HER2+ mutation.

Biologic treatments, such as trastuzumab, are complicated to manufacture and are usually made from living organisms (e.g., humans, animals, microorganisms, or yeast). The approval of biosimilars is based on data demonstrating the biosimilar product is highly similar to an existing FDA-approved biologic product. The reviewed data includes, but is not limited to, animal study findings as well as safety and efficacy results in human trials. As Ogivri was not approved as an interchangeable product, it cannot be substituted for Herceptin without authorization from the prescriber. Ogivri carries the same Boxed Warning as reference product Herceptin regarding the potential for increased risks of heart disease, infusion reactions, lung damage, and harm to developing fetuses. If the patient experiences any of these toxicities, Ogivri should be discontinued.

The FDA has recently been evaluating mechanisms for decreasing health care costs and has stated they are dedicated to using policy to advance the biosimilar approval pathway in order to increase competition for high-cost biologic products. Ogivri is expected to launch in 2019 at a discount to reference product Herceptin. For additional details on the approval of Ogivri, please view the FDA’s press release or manufacturers’ press release.


Drug Shortages and Discontinuations

Update on FDA Efforts to Address Drug Shortages

The U.S. FDA announced on November 30th 2017, the shortage situation related to intravenous (IV) saline products is expected to improve by the end of 2017. Although progress has been made regarding IV saline products, shortages of amino acids for injection continue to be a concern. An ongoing shortage of these products was further exacerbated by Hurricane Maria’s effects on Puerto Rico. Due to disruption at Baxter Pharmaceuticals’ production facility, the FDA has allowed the temporary importation of IV amino acids from other Baxter facilities in the United Kingdom and Italy. Additionally, the FDA is collaborating with other suppliers, including ICU Medical and B. Braun to mitigate the shortage of amino acid products.

The FDA is monitoring the supply of approximately 90 significant medical products, including both drugs and devices, that are manufactured in Puerto Rico. They have stated their commitment to addressing shortage concerns and assisting in the recovery process. For additional information on the FDA’s efforts, please view the most recent FDA News Release.


Discontinuation of Qvar® (beclomethasone dipropionate HFA) Inhalation Aerosol

Earlier this year, Teva Pharmaceuticals announced the discontinuation of Qvar® (beclomethasone diproprionate HFA) metered-dose inhaler (MDI). The discontinuation will affect both the 40 mcg and 80 mcg strengths of the product and is due to a business decision. Teva previously received FDA-approval for the Qvar RediHaler® which contains the same active ingredient as Qvar, but provides delivery of the orally-inhaled steroid via a breath-actuated MDI that does not require hand-breath coordination.

The Qvar MDI formulation will be discontinued upon launch of the new Qvar RediHaler in the first quarter of 2018. Qvar RediHaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age or older. Qvar MDI is indicated for maintenance therapy of asthma as prophylactic therapy in patients 5 years of age and older. NPS is planning to review the new Qvar RediHaler formulation for formulary placement.

For the most up-to-date information on drug shortages and product discontinuations, please visit the ASHP Current Shortages Database or the FDA Drug Shortages Database.




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