ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS
EDITORIAL STAFF EDITOR-IN-CHIEF Maryam Tabatabai PharmD EXECUTIVE EDITOR Anna Schreck Bird PharmD
BEHAVIORAL HEALTH CORNER
DRUG INFORMATION HAPPENINGS & HIGHLIGHTS
RECENT FDA APPROVALS
DEPUTY EDITORS Jessica Czechowski PharmD Lara Frick PharmD, BCPS, BCPP Carole Kerzic RPh Leslie Pittman PharmD
TRENDING TOPICS AUTHORIZATION OF PFIZER-BIONTECH COVID-19 VACCINE IN ADOLESCENTS
BEHAVIORAL HEALTH CORNER: NEW BUPRENORPHINE GUIDELINES FOR OUD
The US FDA has expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine for use in individuals 12 to 15 years old. The EUA was first issued in December 2020 for those ≥ 16 years old. The dosing regimen in adolescents is the same as in adults and includes two 0.3 mL IM doses administered 3 weeks apart. Following review of the data for use in this patient population, the CDC’s ACIP recommended use of the vaccine in individuals ≥ 12 years of age under the conditions specified in the EUA. The American Academy of Pediatrics (AAP) has also endorsed use of this vaccine in adolescents ≥ 12 years of age.
The US HHS has released new buprenorphine guidelines expanding access to opioid use disorder (OUD) treatment by exempting eligible HCPs who are licensed under state law and have a valid DEA registration from certain requirements. These HCPs can be exempt from the certification requirements related to training, counseling, and other ancillary services. Exempt HCPs are limited to treating a maximum of 30 patients at a time, and the exemption only covers prescribing Schedule III, IV, or V drugs; Schedule II medications (e.g., methadone) are not covered by the exemption. If required by state law, advanced practice providers are required to work in collaboration with a physician when prescribing for OUD. Prior to treating patients with buprenorphine for OUD under the exception, HCPs are required to obtain a waiver by submitting a Notice of Intent to SAMHSA.
Safety data reviewed for the authorization included results from 2,260 individuals 12 to 15 years of age participating in a randomized, placebo-controlled, ongoing US study. Overall, AEs were similar to those observed in individuals ≥ 16 years old. The most common AEs in adolescents were injection site pain, fatigue, headache, chills, myalgia, fever, and arthralgia, which generally lasted 1 to 3 days. AEs were typically more common following the second dose, with the exception of injection site pain. In terms of efficacy, the immune response in individuals 12 to 15 years old (n=190) was noninferior to that observed in participants 16 to 25 years of age (n=170). Additionally, 7 days following the second dose, the vaccine was found to be 100% effective in preventing COVID-19 in those vaccinated (n=1,005) who did not have past evidence of SARS-CoV-2 infection. In contrast, there were 16 cases in the placebo group (n=978). The Pfizer-BioNTech vaccine is also being studied in younger individuals, and the requests for expanded authorization to children 2 to 11 years of age and those 6 months to < 2 years of age are expected in September 2021 and in the fourth quarter of 2021, respectively.
2 | JUNE 2021
COVID-19 NOTABLE DEVELOPMENTS The CDC has updated the data regarding selected AEs reported following COVID-19 vaccination, noting that as of May 24, 2021, over 10.2 million doses of the Janssen COVID-19 vaccine have been administered, and the CDC/FDA have confirmed 32 reports of individuals developing thrombosis with thrombocytopenia syndrome (TTS) following vaccination. The CDC notes that TTS is rare for all women and even rarer for women ≥ 50 years and for men. For more resources on COVID-19, visit the Magellan Rx Coronavirus Update webpage. For the most current information, visit the FDA, the CDC, the National Institutes of Health (NIH), the NIH guidelines, and World Health Organization (WHO) websites. State and local health departments also provide valuable information regarding management in local communities. As the COVID-19 landscape is fluid, assumptions are subject to change.
HAPPENINGS & HIGHLIGHTS • The FDA has approved a new presentation, 1,000 mg/20 mL (50 mg/mL), for ferric carboxymaltose (Injectafer®), and a new single-dose regimen. For patients weighing ≥ 50 kg, ferric carboxymaltose can be dosed as 15 mg/kg of elemental iron up to a maximum of 1,000 mg IV as a single-dose treatment course. This is an alternative dosing regimen to the already approved dosing for these patients, which is 750 mg IV in 2 doses separated by ≥ 7 days, for a total cumulative dose of 1,500 mg per course. • Acella has recalled specific lots of 15 mg, 30 mg, 60 mg , 90 mg, and 120 mg NP Thyroid®, Thyroid Tablets, USP (levothyroxine [T4] and liothyronine [T3]) to the consumer level following testing showing subpotent levels (< 90%) of the labeled amount of T3 and/or T4. Patients taking subpotent NP Thyroid may exhibit signs of hypothyroidism. Pregnant women who receive subpotent product could experience miscarriage or adverse fetal outcomes. Elderly patients and those with cardiac disease are also at risk for AEs. Acella has received 43 reports of serious AEs potentially related to the recall.
• Product labeling for SC omalizumab (Xolair®) has been updated to allow for self- or caregiver-administration of the prefilled syringe across all FDA-approved indications. Omalizumab is indicated for certain patients with asthma who are ≥ 6 years old, chronic idiopathic urticaria (CIU) in patients ≥ 12 years of age, and nasal polyps in adults. Previously, the labeling stated that the prefilled syringe should be administered by an HCP. Prior to determining eligibility for self-administration, patients should have no history of anaphylaxis and be given ≥ 3 doses, followed by observation by an HCP to ensure that the patient has no hypersensitivity. HCPs can determine if self- (if ≥ 12 years with adult supervision) or caregiver-administration is appropriate, following targeted risk-benefit assessments for anaphylaxis. • Sanofi has launched famotidine tablets (Zantac 360°™) OTC in the strengths of 10 mg and 20 mg to prevent and relieve heartburn. This new formula, containing famotidine, does not contain the impurity that led Sanofi to issue a voluntary recall of ranitidine (Zantac® OTC) in October 2019.
DRUG INFORMATION HAPPENINGS • The Institute for Clinical and Economic Review (ICER) has published a final evidence report on the effectiveness and value of belimumab (Benlysta®) and voclosporin (Lupkynis™) for treating lupus nephritis. • The US Preventive Services Task Force (USPSTF) has issued final recommendations on using office BP measurement to screen for HTN in adults without known HTN and for obtaining BP readings outside of the clinical setting to confirm diagnosis prior to initiating therapy (Grade A). • The American Heart Association (AHA) has published a scientific statement on the management of stage 1 HTN in adults with a low 10-year risk for CVD to complement the 2017 Hypertension Clinical Practice Guidelines. • The American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) has published a clinical practice guideline on the prescribing of opioids for pain relief following common otolaryngology operations. • The FDA has released a new report on their inspectional activities during the pandemic and their future plans.
UPCOMING PRESCRIPTION DRUG/BIOSIMILAR USER FEE ACT (PDUFA/BsUFA) DATES DRUG NAME MANUFACTURER
FORMULATION THERAPEUTIC CLASS
PROPOSED CLINICAL USE
ANTICIPATED FDA APPROVAL
• Oral • Ornithine decarboxylase/nonsteroidal anti-inflammatory drug (NSAID)
Familial adenomatous polyposis
• IM • Interleukin 2 receptor (IL-2R) antagonist
Acute graft versus host disease
semaglutide (Ozempic®) Novo Nordisk
• SC • Glucagon-like peptide-1 (GLP-1) receptor agonist
Obesity/overweight (≥ 1 weight-related comorbidity)
plasminogen (human) Liminal
• IV • Enzyme replacement therapy
• IV • Amyloid beta protein inhibitor
avapritinib (Ayvakit®) Blueprint Medicines
• Oral • Tyrosine kinase inhibitor
• Oral • Molecular chaperone modulator
ruxolitinib cream Incyte
• Topical • Janus kinase (JAK) inhibitor
Atopic dermatitis (mildmoderate)
• Topical • Blistering agent
• SC • Growth hormone analog (long-acting)
Growth hormone deficiency (pediatrics)
upadacitinib (Rinvoq™) Abbvie
• Oral • JAK inhibitor
Ankylosing spondylitis Psoriatic arthritis
• Ophthalmic • Immunosuppressant
secnidazole (Solosec®) Lupin
• Oral • Nitroimidazole antimicrobial
4 | JUNE 2021
APPROVALS DRUG NAME MANUFACTURER
New Drugs naloxone hydrochloride (Kloxxado™) Hikma
• 505(b)(2) NDA approval 04/29/2021; Standard Review • Indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression, for adult and pediatric patients; it is not a substitute for emergency medical care • Opioid antagonist • Nasal spray: 8 mg/0.1 mL naloxone hydrochloride (equivalent to 7.2 mg of naloxone) as a single dose in a ready-to-use device • Recommended dosage is 1 spray (8 mg) into 1 nostril; prior to administration, place patient in supine position; administer; after dose, place patient on their side and seek immediate emergency medical assistance after the 1st dose; repeat dose with a new device every 2 to 3 minutes, as needed, until emergency personnel arrive if there is no response or the patient relapses; administer repeat doses in alternate nostrils • Product availability is expected in 2H 2021
bupivacaine/meloxicam (Zynrelef™) Heron
• 505(b)(2) NDA approval 05/12/2021; Breakthrough Therapy, Fast Track, Priority Review • Indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty • Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures • Amide local anesthetic plus NSAID • Extended-release solution (bupivacaine/meloxicam) in a kit: 60 mg/1.8 mg, 200 mg/6 mg, 300 mg/9 mg, and 400 mg/12 mg in a single-dose vial (SDV) • Recommended dosage is based on procedure: bunionectomy (up to 60 mg/1.8 mg), open inguinal herniorrhaphy (up to 300 mg/9 mg), or total knee arthroplasty (up to 400 mg/12 mg) • Intended for single-dose soft tissue or periarticular instillation to be administered only in a setting where trained personnel and equipment are available to quickly treat patients who show evidence of neurologic or cardiac toxicity • Boxed warnings for risk of serious CV and GI events • Product availability is expected by July 2021
ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.
RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER
New Drugs continued pegcetacoplan (Empaveli™) Apellis
• NDA approval 05/14/2021; Orphan Drug, Priority Review • Indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) • Complement inhibitor – targeting component 3 (C3) • Solution for injection: 1,080 mg/20 mL (54 mg/mL) in an SDV • Recommended dosage is 1,080 mg (20 mL) by SC infusion twice weekly administered using a commercially available infusion pump with ≥ 20 mL reservoir; may be selfadministered or caregiver-administered after proper training; prescribing information (PI) details instructions for switching from eculizumab (Soliris®) or ravulizumab-cwvz (Ultomiris®) • Boxed warning for serious infections caused by encapsulated bacteria • Available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program
amivantamab-vmjw (Rybrevant™) Janssen
• BLA approval 05/21/2021; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Priority Review, Project Orbis • Indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGF) receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy; continued approval may require demonstration of benefit in confirmatory clinical trials; patients should be selected for treatment based on the presence of EGFR exon 20 insertion mutations • Bispecific EGF receptor-directed and mesenchymal epithelial transition (MET) receptor-directed antibody • Solution for injection: 350 mg/7 mL (50 mg/mL) in an SDV • Recommended dosage is based on body weight and given as an IV infusion by an HCP following dilution weekly for 4 weeks, with the initial dose as a split infusion in week 1 on days 1 and 2, then administered every 2 weeks thereafter until disease progression or unacceptable toxicity; premedications should be administered as described in the PI to decrease the risk for infusion-related reactions; dose reductions and modifications for adverse reactions are also detailed in the PI » Weight < 80 kg: 1,050 mg dose » Weight ≥ 80 kg: 1,400 mg dose
ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant. Glossary: CVD cardiovascular disease
AE adverse effect
DEA Drug Enforcement Administration
BP blood pressure
EUA Emergency Use Authorization
CDC Centers for Disease Control and Prevention
FDA Food and Drug Administration
SAMHSA Substance Abuse and Mental Health Services Administration
CNS central nervous system
HCP healthcare professional
ACIP Advisory Committee on Immunization Practices
COVID-19 Coronavirus Disease 2019 CV cardiovascular
6 | JUNE 2021
GI gastrointestinal HHS Department of Health and Human Services HTN hypertension
SARS-CoV-2 severe acute respiratory syndrome coronavirus 2 SC subcutaneous US United States
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