New Specialty Drug Approvals
New Treatment Approved for Metastatic Breast Cancer: Verzenio®
On September 28, 2017, the U.S. Food and Drug Administration (FDA) approved Verzenio® (abemaciclib) for the targeted treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that progressed after taking hormone altering (endocrine) therapy. In the United States, breast cancer is the most common type of cancer. The National Cancer Institute estimates more than 250,000 women will be diagnosed with breast cancer in 2017. Additionally, about 72% of patients will have tumors that are HR-positive and HER2-negative. Verzenio is a new option for these patients who may not have responded to other treatments and can be given with or without endocrine therapy, depending on prior treatment regimens.
Verzenio works by blocking cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) that are involved in the growth of cancer cells. Two other drugs on the market belonging to this same class are palbociclib (Ibrance®) and ribociclib (Kisqali®). Analysts have noted that patients on Verzenio have lower rates of neutropenia (low white blood cell counts), and Verzenio may be more selective than its competitors as a CDK 4 inhibitor. However, Verzenio’s labeling also includes monitoring for signs and symptoms of blood clots, which is not included in its competitors’ label, and Verzenio also has a higher rate of diarrhea.
Verzenio’s FDA approval was based on two studies evaluating its safety and efficacy as a stand-alone treatment and combination treatment. The MONARCH 1 trial evaluated abemaciclib as a stand-alone treatment in 132 patients with HR-positive, HER2-negative breast cancer that had progressed after endocrine therapy and chemotherapy following cancer spread. In this single-arm trial, 19.7% of patients experienced a complete or partial shrinkage of tumors for a median duration of 8.6 months. The MONARCH 2 trial evaluated Verzenio as a combination treatment with fulvestrant and enrolled 669 patients with HR-positive, HER2-negative breast cancer who had experienced progression after endocrine therapy but had not received chemotherapy after the cancer spread. Patients treated with abemaciclib + fulvestrant experienced a median progression-free survival of 16.4 months compared to 9.3 months for patients who received placebo + fulvestrant. The most common side effects of Verzenio include diarrhea, nausea, abdominal pain, infections, fatigue, low red blood cells, low white blood cells, decreased appetite, vomiting, headache, and low platelet counts. During clinical trials, diarrhea occurred in 86% of patients taking Verzenio + fulvestrant and 90% of patients taking Verzenio alone. Other serious side effects include the potential for low white blood cell counts, increased liver blood tests, and blood clots. Verzenio also has the potential to cause harm to a developing fetus.
Verzenio is available as a 50 mg, 100 mg, 150 mg, and 200 mg oral tablet with recommended dosing of 150 mg twice daily when given in combination with fulvestrant and 200 mg twice daily when given alone. The average wholesale price (AWP) per tablet is $234.60. NPS is planning to review Verzenio for placement on the national formularies. For additional details on Verzenio, please view the FDA’s press release.
New Drug Approvals
First Triple Drug Combination Inhaler for COPD: Trelegy Ellipta®
Trelegy Ellipta® received FDA approval on September 18, 2017 as a long-term maintenance therapy for patients with chronic obstructive pulmonary disease (COPD). COPD is a serious and progressive disease that worsens over time and is thought to affect 384 million people worldwide. Trelegy Ellipta, the product of an Innoviva and GlaxoSmithKline collaboration, is the first inhaler to combine three common COPD treatments into a single once-daily treatment. The device contains a dry powder for inhalation of the following medications: fluticasone furoate (an inhaled corticosteroid), umeclinidium (an anticholinergic), and vilanterol (a long-acting beta2-adrenergic agonists [LABA]). The triple combination inhaler improves convenience for patients who are receiving Breo Ellipta® (fluticasone furoate / vilanterol [FF/V]) and require additional bronchodilation or who are already using Breo Ellipta and Incruse Ellipta® (umeclinidum).
The efficacy of Trelegy Ellipta was demonstrated in two multicenter, randomized, double-blind, parallel-group, 12-week treatment trials. Each trial included 206 patients who were treated with umeclidinium 62.5 mcg + FF/V 100 mcg/25 mcg or placebo + FF/V 100 mcg/25 mg. Half of those enrolled identified themselves as smokers with an average smoking history of 48 pack-years. The primary endpoint was a measure of lung function as assessed by the change in trough forced expiratory volume in 1 second (FEV1) from baseline to day 85. The change in weighted mean FEV1 from baseline to day 84 measured 0 to 6 hours after the previous dose was also assessed as a secondary endpoint.
Both trials demonstrated statistically significant improvements for the primary and secondary endpoints for the triple combination compared to FF/V + placebo. The studies also found patients who were being treated with umeclidinium and FF/V utilized their rescue medication less than the patients who received placebo and FF/V. The safety profile of Trelegy Ellipta was similar to previous reports of the individual components. The most common adverse events in the clinical trials were upper respiratory infections, worsening COPD, pneumonia, and headaches.
Trelegy Ellipta is available as an inhalation pack of 30 inhalations and a 14-inhalation institutional pack. It is administered as one inhalation once daily with an average wholesale price (AWP) for a one-month supply of $636.00. NPS is planning to review Trelegy Ellipta for placement on the national formularies. For additional details, please view the manufacturer’s press release.
Opdivo® Receives Expanded Indication
At the end of September 2017, the FDA granted a new indication to cancer drug Opdivo® (nivolumab). It received accelerated approval for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib). HCC is the most common type of liver cancer and is usually caused by infection with the Hepatitis B virus (HBV) or Hepatitis C virus (HCV). This year, it is estimated there will be 41,000 new cases of liver cancer in the U.S. with 29,000 deaths due to the disease. The accelerated approval of Opdivo for this indication was based on tumor response rate and durability of response as determined from the CheckMate -040 trial. As a result, the continued approval for this use may require verification of benefit in confirmatory trials.
CheckMate -040 is a Phase 1/2, open-label, multicenter study enrolling patients with HCC that had progressed or did not respond to sorafenib. In the study population of 154 patients, 14.3% responded to treatment with Opdivo with 1.9% of patients exhibiting a complete response and the remainder having a partial response. The duration of response ranged from 3.2 to 38.2+ months with 91% of responses lasting 6 months or longer and 55% lasting 12 months or longer. Serious adverse reactions reported by at least 2% of patients included: fever, fluid accumulation in the stomach cavity, back pain, general health deterioration, stomach pain, and pneumonia. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (36%), stomach pain (34%), itching (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). Discontinuation due to adverse reactions occurred in 11% of patients while 32% of patients needed to delay therapy due to an adverse reaction.
Bristol-Myer Squibb’s Opdivo is also indicated for treatment of a number of other cancers including: unresectable or metastatic melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. It is given by intravenous (IV) infusion at a dose of 240 mg every 2 weeks for HCC. For additional details on Opdivo’s new indication of HCC, please view the manufacturer’s press release.
FDA Safety Update
Drug Safety Communication Issued for Ocaliva®
On September 21, 2017, the U.S. FDA released an official warning that Ocaliva® (obeticholic acid) is being incorrectly dosed in certain patients, leading to an increased risk of serious liver injury and death. Ocaliva received accelerated approval in 2016 for the treatment of primary biliary cholangitis (PBC) alone or in combination with ursodeoxycholic acid (UDCA) in adults who do not respond to or tolerate UDCA. PBC is a rare, long-term liver condition characterized by inflammation of the bile ducts leading to a buildup of bile in the liver. The bile accumulation eventually leads to a decline in liver function.
The usual starting dose of Ocaliva is 5 mg by mouth daily which can be increased to 10 mg daily. In patients with moderate to severe liver impairment, it is recommended the starting dose be decreased to 5 mg weekly with a maximum dose of 10 mg twice weekly. Prior to starting Ocaliva, clinicians should determine baseline liver function and initiate therapy according to the patient’s liver function. Frequent liver function tests should be performed so appropriate dose adjustments or therapy interruptions can be performed. Ocaliva should be discontinued in cases of suspected liver injury as determined by declining liver blood tests or adverse liver-related reactions that are not expected based on the patient’s disease severity.
Through the FDA’s Adverse Event Reporting System (FAERS), it was found patients who had moderate to severe liver impairment were receiving the 5 mg daily dose. Since Ocaliva’s approval date in May 2016, there have been 19 reported cases of death, seven of which were due to worsening of PBC disease. Moderate to severe decreased liver function was reported in seven of the eight cases of which Ocaliva 5 mg was prescribed for daily use rather than the maximum of 10 mg twice weekly. Additionally, there were also 11 cases of serious liver injury of which six cases involved patients taking doses too high for their baseline liver function; three of these patients died (included in the previously 19 reported cases of death). Ocaliva was discontinued in four of these six cases and one patient subsequently experienced symptom resolution and an improvement in liver blood tests. The remaining five cases of serious liver injury occurred in patients with no or mild decreases in liver function before starting therapy. Symptom resolution and/or improved liver blood tests occurred in two of these patients following discontinuation of the medication; the remaining three patients did not report what occurred following Ocaliva discontinuation. The FAERS program relies on reports submitted to the FDA, and therefore additional cases may have occurred which have not been reported.
Patients are instructed to contact their healthcare provider with questions or concerns regarding Ocaliva. Symptoms to report to the prescriber would include new or worsening severe skin itching. Patients should also contact their healthcare provider immediately if any of the following develop:
- New or worsening fatigue
- Weight loss
- Abdominal pain
- Decreased appetite
- Nausea and vomiting
- Change in behavior or confusion
- Symptoms such as anxiety or unease
- Abdominal swelling
- Yellow eyes or skin
- Bloody stools
Any adverse reactions experienced with the use of this product should be reported to FDA’s MedWatch Adverse Event Reporting program online at: www.fda.gov/MedWatch/report or by calling 1-800-332-1088. To view the FDA’s Drug Safety Communication in its entirety, please visit the FDA website.
New Shingles Vaccine Receives FDA Approval: Shingrix®
The U.S. FDA has approved a new vaccine for the prevention of shingles in adults aged 50 years and older: Shingrix® (zoster vaccine recombinant, adjuvanted). Shingles, also known as herpes zoster, is caused by the reactivation of the varicella zoster virus (VZV) after previous infection with chicken pox and is most commonly experienced in older adults. Shingrix is administered via injection into the muscle in two doses and has demonstrated efficacy of greater than 90% across all age groups in the prevention of shingles. In addition, Shingrix has demonstrated sustained efficacy over a period of 4 years. In September of this year, Shingrix® received a unanimous vote in favor of approval based on efficacy and safety data reviewed by an advisory panel to the FDA.
Shingrix is expected to compete directly with the other currently available shingles vaccine, Zostavax® (zoster vaccine live). Zostavax is also indicated for the prevention of shingles in people age 50 and older. While there have been ongoing concerns of the diminished immunity over time observed in patients over 70 years of age vaccinated with Zostavax®, Shingrix has demonstrated more effective immunity against shingles for many years following vaccination. The Centers for Disease Control and Prevention (CDC) currently recommends routine vaccination for shingles in those age 60 years and older.
The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to make a decision regarding the inclusion of Shingrix in the updated vaccine recommendations on October 25, 2017. NPS plans to provide ongoing communication regarding the commercial launch of Shingrix in the U.S. and is planning to review the product for formulary placement. For additional information on the U.S. approval of Shingrix, please view the manufacturer’s press release.
National Prescription Drug Take Back Day: Saturday, October 28th
The U.S. Drug Enforcement Administration (DEA) hosted its first National Drug Take Back event in September of 2010, and since that time the bi-annual event to safely dispose of unused medications has grown in popularity and participation. In April of this year, the event resulted in collection of more than 900,000 pounds of unused prescription medications. The DEA, in collaboration with local law enforcement and community partners, organize a National Take Back Day for unused medications twice a year, usually each spring and fall.
The objective of the National Prescription Drug Take Back events is to provide a convenient and safe way to dispose of prescription drugs, while educating the public regarding the potential for abuse and addiction to medications. This fall, the official event is scheduled for Saturday, October 28, 2017 from 10:00 am to 2:00 pm. Please visit the DEA website or call 1-800-882-9539 to locate a collection site near you. Unused medications can also be disposed of year-round at local collection sites; for additional details on disposing of medications outside of a National Prescription Drug Take Back Day event, please visit: www.rxdrugdropbox.org.
FDA Commissioner Travels to Puerto Rico to Assess Damages, Drug Shortages Possible
Puerto Rico is home to several major pharmaceutical companies including Baxter, Pfizer, Merck, and others. Along with 30 medical-device facilities, there are manufacturers that produce treatments for cancer, HIV, and organ transplant recipients. Pharmaceutical manufacturing is a major component of Puerto Rico’s economy and comprised 72% of the exports in 2016 and employed approximately 90,000 people.
Due to the lack of cell phone service, communication has been poor but manufacturing facilities are reporting they are still operating, though at a reduced level. While some facilities may not have sustained critical damage, employees are dealing with the personal effects of the disaster and those who are ready to return to work may be unable to make the commute due to road damage. The incapacitated power grid has resulted in facilities relying on diesel-fueled generators to refrigerate their products and some facilities are running at a severely limited capacity. Dr. Scott Gottlieb, the current FDA Commissioner, travelled with staff from the Department of Homeland Security to meet with the FDA’s 100 employees in San Juan as well as assess the damage to the island’s drug manufacturing facilities. He plans to deliver more satellite phones to FDA staff to help improve communication and is working to assess the diesel fuel needs for continued operations. Federal and industry officials are working to relocate some manufacturing to the mainland as private planes are granted clearance to bring supplies and leave with finished products. Dr. Gottlieb has stated the people of Puerto Rico are the number one priority, and the FDA is working to help the medical product manufacturing industry recover.
The FDA has been monitoring 40 high-priority drugs, 12 of which are not produced at any other facilities. These essential drugs could become in short supply if the manufacturing and distribution disruptions continue. Baxter International, the largest supplier of intravenous bags of dextrose and sodium chloride (saline), has lost multiple production days on smaller-volume bags commonly used for heart surgery or for compounding other medications. This has led to an allocation situation where fixed amounts are being distributed to U.S. hospital customers based on average demand. Despite a dynamic and challenging situation, the FDA has been proactive in addressing emerging issues. However, shortages and manufacturing delays may become more frequent as supplies are exhausted while Puerto Rico moves towards recovery. To view the FDA Commissioner’s most recent statement on the recovery efforts, please visit the FDA website.
Carbidopa/Levodopa Extended-Release Tablets on Shortage
On September 27, 2017, the FDA posted a shortage notification on the generic carbidopa/levodopa extended-release (ER) tablet. This medication is indicated for the treatment of parkinsonism and Parkinson’s disease. Accord Healthcare Inc. is currently experiencing a shortage of the 25 mg/100 mg strength tablet and cites manufacturing delays as the reason. Partial stock coverage is available for the 50 mg/100 mg strength tablet supplied in a 100-count bottle with an expected time frame for full stock recovery of this strength tablet in 3 months. Mylan Pharmaceuticals Inc.’s generic products (25 mg/100 mg and 50 mg/200 mg tablet) are currently also out-of-stock with an estimated recovery of product by mid-October. Other generic manufacturers, including Merck Sharp & Dohme Corp. and Sun Pharmaceutical Industries Inc., currently have stock available and the latter has increased capacity to support additional demands.
Update on Atenolol Shortage
The shortage of generic atenolol tablets was first posted on FDA’s website on July 26, 2017 and a number of manufacturers continue to have product on shortage as of mid-October. Atenolol is a selective beta-blocker used for several indications including: acute heart attack, chest pain, and high blood pressure. Mylan Pharmaceuticals Inc. and Sandoz do not currently have an estimated date for recovery of inventory and cite a shortage of the active ingredient as the cause. Teva Pharmaceuticals has limited inventory and product allocation is expected to continue until late into the 4th quarter of 2017. Zydus Pharmaceuticals USA Inc. currently has all strengths of generic atenolol available and has increased capacity to support additional demand.
Apotex Discontinues Montelukast Chewable Tablets
On September 11, 2017, the FDA posted Apotex Corporation would be discontinuing its line of montelukast sodium chewable tablets. The two strengths affected will be 5 mg (NDC 60505-3574-09) and 4 mg (NDC 60505-3574-03 and NDC 60505-3573-03). The FDA website did not list any additional details about the decision to discontinue the medications. Other generic versions of the chewable allergy/asthma medication are expected to remain commercially available.
One Strength of Symbyax® (olanzapine / fluoxetine) Discontinued
On September 25, 2017, the FDA announced Eli Lilly and Company’s intent to discontinue the 12 mg/25 mg strength capsule of Symbyax® (olanzapine / fluoxetine) (NDC 00002-3232-30). This medication is a combination of an atypical antipsychotic and a selective serotonin reuptake inhibitor (SSRI) approved to treat depressive episodes associated with bipolar I disorder. The decision to stop the manufacturing of the 12 mg/25 mg strength of this medication was not related to safety or efficacy of the medication. The four additional approved doses of Symbyax (12 mg/50 mg, 3 mg/25 mg, 6 mg/25 mg, and 6 mg/50 mg) will remain available on the U.S. market as will generic versions of the 12 mg/25 mg capsule.
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