FDA Updates – New Drug Approvals from Q1 and Q2 2020

It has been quite a while since our last update, so this is a big one! As a reminder, this is a continuation of our new blog series to update you on recent FDA drug approvals, new indications, and other changes. You can find the recap or notable FDA drug changes (AdCom, PDUFDA, etc.) for January – June 2020 below. If we are missing information or you’d like more information about one of the noted changes, feel free to contact us.

Date Name Company Indication
Date Product Company Indication
1/6/2020 Fiasp Novo Nordisk to improve glycemic control in adult and pediatric patients with diabetes mellitus
1/8/2020 Keytruda Merck treatment of patients with bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)
1/9/2020 Mycamine Astellas treatment of candidemia, candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination in adults and children 4 months of age and older
1/9/2020 Ayvakit Blueprint Medicines Corp treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
1/13/2020 Valtoco Neurelis

cute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older

1/13/2020 Numbrino Lannett Company, Inc Local nasal analgesia / anesthetic
1/17/2020 Ozempic Novo Nordisk to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
1/22/2020 Tepezza Horizon Therapeutics treatment of adults with thyroid eye disease
1/22/2020 Micra AV Medtronic Leadless AV synchronous pacemaker
1/24/2020 Tazverik Epizyme treatment of epithelioid sarcoma
1/27/2020 Dificid Merck treatment of Clostridioides difficile-associated diarrhea (CDAD) in children aged 6 months and older
1/28/2020 Trijardy XR Boehringer Ingelheim / Eli Lilly to improve glycemic control in adults with type 2 diabetes mellitus
1/28/2020 Ajovy Teva New auto-injector approved for prevention of migraine
1/29/2020 Monoferric Pharmacosmos Therapeutics

treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease

1/31/2020 Palforzia Aimmune Therapeutics mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4-17
2/6/2020 Audenz Seqirus to help protect individuals six months of age and older against influenza A (H5N1)
2/10/2020 Pemfexy Eagle Pharmaceuticals ocally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin
2/13/2020 Pizensy Braintree treatment of chronic idiopathic constipation in adults
2/14/2020 Twirla Agile Therapeutics method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate
2/17/2020 Voltaren Arthritis Pain GlaxoSmithKline for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older)
2/17/2020 Pataday Twice Daily Relief Alcon temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander
2/17/2020 Pataday Once Daily Relief Alcon temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use
2/21/2020 Anjeso Baudax Bio

treatment of moderate to severe pain in adults, either by itself of with other nonsteroidal anti-inflammatory drug (NSAID) analgesics

2/21/2020 Nexletol Esperion

to lower LDL cholesterol in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease

2/21/2020 Vyepti Lundbeck preventive treatment of migraine in adults
2/24/2020 Trulicity Eli Lilly to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors
2/24/2020 Fluad Quadrivalent Seqirus to protect adults aged 65 years or older against seasonal influenza
2/26/2020 Nexlizet Esperion for use on top of maximally tolerated statins in adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who haven’t met their low-density lipoprotein cholesterol (LDL-C) targets
2/27/2020 Barhemsys Acacia Pharma for the prevention and treatment of post operative nausea and vomiting in adult patients
2/27/2020 Nurtec ODT Biohaven Pharmaceutical acute treatment of migraine in adults
3/2/2020 Sarclisa Sanofi-Genzyme

treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor

3/2/2020 Generic Daraprim Cerovene treatment of toxoplasmosis when used with a sulfonamide
3/2/2020 Pizensy Sebela Treatment of Chronic Idiopathic Constipation in Adults
3/5/2020 Durysta Allergan to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients
3/6/2020 Isturisa Recordati/Novartis

for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease

3/9/2020 Ofev Boehringer Ingelheim Treatment of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
3/11/2020 Opdivo/Yervoy Bristol Myers Squibb treatment of (HCC) in patients who have previously been treated with sorafenib
3/20/2020 Epclusa Gilead for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection
3/24/2020 Eucrisa Pfizer Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis
3/26/2020 Zeposia Bristol Myers Squibb

treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

3/27/2020 Triferic AVNU Rockwell Medical for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients
3/30/2020 Imfinzi AstraZeneca in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)
3/30/2020 Taltz Eli Lilly treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
4/1/2020 Sevenfact Laboratoire Francais du Fractionnement et des Biotechnologies

treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors

4/3/2020 Reblozyl Bristol Myers Squibb to treat patients with myelodysplastic syndromes (MDS) who require red blood cell transfusions and have failed an erythropoiesis stimulating agent
4/13/2020 Koselugo AstraZeneca

treatment of pediatric patients aged 2 years and older with type 1 neurofibromatosis (NF1) with symptomatic, inoperable plexiform neurofibromas

4/15/2020 Jelmyto UroGen Pharma Treatment of Low-Grade Upper Tract Urothelial Cancer
4/17/2020 Tukysa Seattle Genetics treatment of advanced HER2-positive breast cancer
4/17/2020 Pemazyre Incyte treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
4/21/2020 Emerphed Nexus Pharmaceuticals Ready-to-Use Injection for Hypotension During Anesthesia
4/21/2020 Imbruvica AbbVie in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
4/22/2020 Trodelvy Immunomedics treatment of metastatic triple-negative breast cancer (TNBC)
4/24/2020 MenQuadfi Sanofi prevention of invasive meningococcal disease in persons 2 years of age and older
4/27/2020 Ongentys Neurocrine Biosciences, add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes
4/29/2020 Zejula GlaxoSmithKline maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
5/1/2020 Darzalex Faspro Janssen Treatment of patients with multiple myeloma
5/2/2020 Remdesivir Gilead treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease
5/4/2020 Fensolvi Tolmar Pharmaceuticals treatment of pediatric patients two years of age and older with central precocious puberty (CPP)
5/5/2020 Farxiga AstraZeneca to reduce the risk of cardiovascular death or hospitalization in heart failure patients with a reduced ejection fraction (HFrEF) and with or without Type 2 diabetes
5/6/2020 Tabrecta Novartis

adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test

5/6/2020 Elyxyb Dr. Reddy’s acute treatment of migraine with or without aura in adults
5/8/2020 Retevmo Loxo / Eli Lilly

Advanced medullary thyroid cancer (MTC) or MTC that has spread, in patients 12 and older who require systemic therapy (a treatment option that spreads across the entire body, is not targeted) – AND – Advanced RET fusion-positive thyroid cancer in those age 12 and older that requires systemic therapy that has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy – AND – Non-small cell lung cancer (NSCLC) that has spread in adults.

5/8/2020 Lynparza AstraZeneca As first-line maintenance treatment of HRD-positive* advanced ovarian cancer, defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability, following complete or partial response to first-line platinum-based chemotherapy
5/15/2020 Pomalyst Bristol Myers Squibb treatment of AIDS-related Kaposi sarcoma that is resistant to highly active antiretroviral therapy (HAART) or that occurs in HIV-negative patients
5/15/2020 Rubraca Clovis use in patients with metastatic castration-resistant prostate cancer (mCRPC) that harbors deleterious BRCA mutations (germline and/or somatic)
5/15/2020 Opdivo/Yervoy Bristol Myers Squibb first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) whose tumors express PD-L1 (≥ 1%)
5/18/2020 Qinlock Deciphera Pharmaceuticals treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib
5/20/2020 Tecentriq Genentech initial treatment for adults with metastatic NSCLC whose tumours have high PD-L1 expression, without EGFR or ALK mutations
5/20/2020 Lynparza AstraZeneca patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC)
5/21/2020 Ferripox Chiesi

treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate

5/21/2020 Kynmobi Sunovion for the acute, intermittent treatment of ‘off’ episodes in patients with Parkinson’s disease (PD)
5/22/2020 Alunbrig Takeda for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
5/26/2020 Phexxi Evofem Biosciences to prevent pregnancy in women of reproductive potential
5/27/2020 Sirturo Janssen as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB)
5/27/2020 IV artesunate Amivas to treat adults and children with severe malaria
5/27/2020 Dupixent Sanofi/Regeneron for children aged 6-11 years with moderate to severe atopic dermatitis
5/27/2020 VESIcare LS Astellas treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older
5/27/2020 Cerianna Siemens Healthineers / Zionexa PET Imaging Agent for Use in Patients with Recurrent or Metastatic Breast Cancer
5/28/2020 Tauvid Avid Radiopharmaceuticals / Eli Lilly

positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD)

5/29/2020 Cyramza Eli Lilly First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
6/1/2020 Oriahnn AbbVie / Neurocrine Biosciences Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women
6/1/2020 Brilinta AstraZeneca with aspirin to cut the risk for a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke
6/1/2020 Zilxi Menlo Therapeutics treatment of inflammatory lesions of rosacea in adults
6/1/2020 Tecentriq Genentech treatment of people with unresectable or metastatic hepatocellular carcinoma or HCC, who have not received prior systemic therapy
6/1/2020 Taltz Eli Lilly treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation
6/9/2020 Recarbrio Merck

to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)

6/10/2020 Opdivo Bristol Myers Squibb Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy
6/11/2020 Uplinza Viela Bio Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)
6/11/2020 Semglee Mylan / Biocon to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes
6/12/2020 Gardasil 9 Merck prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
6/12/2020 Tivicay PD ViiV

reatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above

6/15/2020 Zepzelca PharmaMar / Jazz Pharmaceuticals

treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression, after platinum-based chemotherapy

6/16/2020 EndeavorRx device Akili Interactive for the improvement of attention function, as assessed by computer-based testing
6/17/2020 Keytruda Merck monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
6/18/2020 Cosentyx Novartis treatment of active nonradiographic axial spondyloarthritis (nr-axSpA)
6/18/2020 Lyumjev Eli Lilly treatment of adults with type 1 and type 2 diabetes
6/18/2020 Crysvita Ultragenyx Pharmaceutical / Kyowa Kirin

treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older

6/19/2020 Tazverik Epizyme treatment of relapsed or refractory (R/R) follicular lymphoma in adult patients with tumors harboring an EZH2 mutation
6/19/2020 Ilaris Novartis include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA)
6/19/2020 Gimoti Evoke Pharma for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis
6/22/2020 ReActiv8 Mainstay Medical

to treat intractable chronic low back pain associated with multifidus muscle dysfunction found on imaging or physiologic testing in adults who have failed other therapies and are not candidates for spine surgery

6/22/2020 Xpovio Karyopharm

treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy

6/24/2020 Keytruda Merck recurrent or metastatic cutaneous squamous cell carcinoma that can’t be cured by surgery or radiation
6/26/2020 Fintepla Zogenix treatment of seizures associated with Dravet syndrome in children age 2 years and older
6/26/2020 Mycapssa Chiasma

long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide

6/29/2020 Phesgo Genentech injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer
6/29/2020 Keytruda Merck in previously untreated patients with metastatic or inoperable colorectal cancer and one of two biomarkers—microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors
6/30/2020 Dojolvi Ultragenyx Pharmaceutical

a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)

Stay tuned, as we will continue to update this FDA new drug approval series regularly. We hope you enjoy your 4th of July, and look for our next post in this series to publish in early October!

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