FDA Approval LIST. WellINFORMED. Generic Name(s) Brand Name (manufacturer) Therapeutic Use. Brief Description. Potential Impact.

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1 FDA Approval LIST Formulary management is one way to bring down drug costs, and deciding which medications to include on a formulary is part of this process. New drug releases are generally associated with higher costs, and being aware of new medications coming to market assists with cost containment. Market impact (adoption and use of a new medication) can cause drug costs to increase, but WellDyneRx helps you take proactive measures to manage your plan s drug spend. The Q FDA Approval list is shown below. Xepi TM (Medimetriks) ozenoxacin cream 1% Impetigo Xepi is a topical quinolone antibiotic indicated for the treatment of impetigo attributable to Staphylococcus aureus (including MRSA) or Streptococcus pyogenes in patients 2 months of age and older. The product is applied topically twice daily for five days and is the first topical treatment for impetigo to be approved in more than 10 years. Admelog (Sanofi-Aventis) insulin lispro Diabetes Admelog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog can be administered by injection under the skin or via insulin pump and dosing individualized by patient needs. HEPLISAV-B TM (Dynavax) hepatitis B vaccine recombinant adjuvanted Prevention Hepatitis B HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults. Lonhala Magnair TM (Sunovion) glycopyrrolate COPD Lonhala Magnair is indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This is the first nebulized long-acting muscarinic antagonist (LAMA) approved for COPD in the U.S. and first use of Magnair (nebulizer used to deliver the medication). Recommended dose is one vial of Lonhala inhaled twice daily. 7

2 Steglatro TM (Merck and Pfizer) ertugliflozin Diabetes Steglatro is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The recommended starting dose is 5 mg daily taken in the morning, with or without food and may be increased to 15 mg daily for those requiring additional glycemic control. Ozempic (Novo Nordisk) semaglutide Type 2 diabetes Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This medication is administered once weekly, on the same day each week and can be taken any time of the day, with or without meals. Recommended dose is 0.25 mg once weekly and after 4 weeks increase dose to 0.5 mg weekly. If after at least 4 weeks additional glycemic control is needed, increase to 1 mg once weekly. Ogivri TM (Mylan and Biocon) trastuzumab-dkst Breast or metastatic stomach cancer Ogivri, a biosimilar to Genetech s Herceptin (trastuzumab) is indicated for treating patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. Dosing is dependent on the indication. Sublocade (Indivior) buprenorphine Opioid use disorder Sublocade is indicated for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of 7 days and is the first once-monthly injectable buprenorphine product. Recommended dose is 300 mg subcutaneously (SC) once monthly for the first 2 months, then 100 mg once monthly as a maintenance dose. 8

3 Juluca (ViiV) dolutegravir and rilpivirine HIV Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) indicated for the treatment of HIV-1 infection in adults whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. The recommended dose is one tablet daily with a meal. This is the first complete treatment regimen containing only two drugs to treat HIV-1. Current standard HIV treatment consists of three or more drugs. Hemlibra (Genentech) emicizumabkxwh Hemophilia A Hemlibra is a bi-specific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients with hemophilia A with factor VIII inhibitors. The recommended dose is 3 mg/kg by SC injection once weekly for the first 4 weeks, followed by 1.5 mg/ kg SC once weekly. This is the first new medication in nearly 20 years to treat patients with hemophilia A who have developed inhibitors to factor VIII replacement therapies. Mepsevii TM (Ultragenyx) vestronidase alfa-vjbk MPS VII Mepsevii is a recombinant human lysosomal beta glucuronidase indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). MPS VII is an extremely rare, progressive condition that affects most tissues and organs. The recommended dosage is 4 mg/kg administered every two weeks as an intravenous infusion. Fiasp (NovoNordisk) insulin aspart Diabetes Fiasp is a rapid-acting insulin indicated to manage blood sugar levels for adults with either type 1 or type 2 diabetes. Because it has been modified to increase absorption, the effects may begin as soon as 20 minutes after injection. Dosing is individualized and given before a meal or within 20 minutes of beginning to eat. Abilify Mycite (Otsuka and Proteus) aripiprazole tablets with sensor Schizophrenia Bipolar Abilify MyCite is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. This is the first drug approved in the U.S. containing a digital ingestion tracking system. Abilify MyCite has an ingestible sensor embedded in the pill that records that the medication was taken. 9

4 Qtern dapagliflozinsaxagliptin Diabetes Qtern is a fixed-dose combination of two antihyperglycemic agents (dapagliflozin and saxagliptin) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who have inadequate control with Farxiga (dapagliflozin) or who are already treated with Farxiga and Onglyza. The recommended dose is one tablet orally once daily. Fasenra benralizumab Eosinophilic asthma Fasenra is an interleukin-5 antibody indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. The recommended dose is 30 mg SC every 4 weeks for the first three doses, followed by once every 8 weeks thereafter. Prevymis TM (Merck Sharp Dohme) letermovir CMV prophylaxis Prevymis is cytomegalovirus (CMV) DNA complex inhibitor indicated for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients (R+) of an allogenic hematopoietic stem cell transplant (HSCT). The recommended dose is 480 mg orally or IV once daily initiated between day 0 and day 28 post-transplantation and continued through day 100 post-transplantation. Vyzulta (Bausch + Lomb) latanoprostene bunod opth soln, 0.024% Glaucoma Vyzulta is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The recommended dose is one drop into the affected eye(s) once in the evening. Calquence acalabrutinib Mantle cell lymphoma Calquence is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The recommended dose is 100 mg orally every 12 hours and medication should be swallowed whole and can be given with or without food. MCL is an aggressive cancer and Calquence provides a new treatment option for patients who have not responded to treatment or have relapsed. 10

5 Shingrix (GlaxoSmithKline) zoster vaccine recombinant, adjuvanted Shingles vaccine Shingrix is a non-live recombinant vaccine indicated for prevention of herpes zoster (shingles) in adults 50 years and older. This vaccine is administered in 2 doses of 0.5 ml s each at 0 and 2 to 6 months. The US Centers for Disease Control and Prevention s (CDC) advisory committee recommends Shingrix as the preferred vaccine for prevention of shingles in adults aged 50 and up. Yescarta TM (Kite) axicabtagene ciloleucel Lymphoma Yescarta is a chimeric antigen receptor (CAR)-T cell gene therapy indicated for the treatment of adult patients with relapsed or refractory forms of non-hodgkin lymphoma (NHL) after two of more lines of systemic therapy. This is the 2nd gene therapy approved and treatment is customized using patient s own immune system and will only be available through healthcare facilities. Duzallo (Ironwood) allopurinol/ lesinurad Gout Duzallo, a combination of lesinurad, a URAT1 inhibitor, and allopurinol, a xanthine oxidase inhibitor, is indicated for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. The recommended dose is one tablet daily with food and water. Kymriah TM (Novartis) tisagenlecleucel Acute lymphoblastic leukemia (ALL) Kymriah is a genetically modified T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Treatment is customized using patient s own immune system and will only be available through healthcare facilities. Gocovri TM (Adamas) amantadine er Dyskinesia Gocovri is an uncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor indicated for the treatment of involuntary muscle movement, or dyskinesia, in adult patients with Parkinson s disease receiving levodopa-based therapy. This medication is an extended-release formulation of generically available amantadine. The recommended dose is 274 mg given at bedtime (dosed at 137 mg at bedtime for 1 week and then increased to 274 mg). Thank you for reading the Q Well Informed. Please contact your Account Executive if you have any questions. 11