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59 new drugs approved by US FDA in 2018

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Dr KK Aggarwal    11 January 2019

Last year, the US FDA approved a record 59 new drugs, which included 19 first-in-class agents, 34 novel drugs for rare diseases, and a record seven biosimilars.

In 2017, 46 new drugs had been approved; in 2016, 22 drugs received the FDA green signal and in between 2009 and 2017, on an average 33 new drugs were accorded FDA approval.

Here is a list of the drugs approved by the FDA in 2018.

 

Ultomiris

ravulizumab

To treat paroxysmal nocturnal hemoglobinuria (PNH)

Elzonris

tagraxofusp-erzs

To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Asparlas

calaspargase pegol-mknl

To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years

Motegrity

prucalopride

To treat chronic idiopathic constipation

Xospata

gilteritinib

To treat patients who have relapsed or refractory acute myeloid leukemia (AML)

Firdapse

amifampridine

To treat  Lambert-Eaton myasthenic syndrome in adults

Vitrakvi

larotrectinib

To treat patients whose cancers have a specific genetic feature (biomarker)

Daurismo

glasdegib

To treat newly-diagnosed AML in adult patients

Gamifant

emapalumab-lzsg

To treat primary hemophagocytic lymphohistiocytosis  

Aemcolo

rifamycin

To treat travelers’ diarrhea

Yupelri

revefenacin

To treat patients with chronic obstructive pulmonary disease (COPD)

Lorbrena

lorlatinib

To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer

Xofluza

baloxavir marboxil

For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours

Talzenna

talazoparib

For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation

Tegsedi

inotersen

To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

Revcovi

elapegademase-lvlr

To treat Adenosine Deaminase-Severe Combined Immuno-deficiency (ADA-SCID)

Nuzyra

omadacycline

To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections

Seysara

sarecycline

To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years 

Libtayo

cemiplimab-rwlc

To treat cutaneous squamous cell carcinoma

Vizimpro

dacomitinib

To treat metastatic non-small-cell lung cancer

Emgality

galcanezumab-gnlm

For the preventive treatment of migraine in adults

Copiktra

duvelisib

To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma

Ajovy

fremanezumab-vfrm

For the preventive treatment of migraine in adults

Lumoxiti

moxetumomab pasudotox-tdfk

To treat hairy cell leukemia

Pifeltro

doravirine

To treat HIV-1 infection in adult patients

Xerava

eravacycline

To treat complicated intra-abdominal infections in patients ≥ 18 years 

Takhzyro

lanadelumab

To treat types I and II hereditary angioedema

Oxervate

cenegermin-bkbj

To treat neurotrophic keratitis

Diacomit

stiripentol

To treat seizures associated with Dravet syndrome in patients ≥2 years taking clobazam

Galafold

migalastat

To treat adults with Fabry disease

Annovera

segesterone acetate and ethinyl estradiol vaginal system

New vaginal ring used to prevent pregnancy for an entire year 

Onpattro

patisiran

To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients

Poteligeo

mogamulizumab-kpkc

To treat two rare types of non-Hodgkin lymphoma

Mulpleta

lusutrombopag

To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure

Omegaven

fish oil triglycerides

As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis

Orilissa

elagolix sodium

For the management of moderate to severe pain associated with endometriosis

Krintafel

tafenoquine

For the radical cure (prevention of relapse) of Plasmodium vivax malaria

Tibsovo

ivosidenib

To treat patients with relapsed or refractory acute myeloid leukemia 

TPOXX

tecovirimat

To treat smallpox

Braftovi

encorafenib

To treat unresectable or metastatic melanoma 

Mektovi

binimetinib

To treat unresectable or metastatic melanoma 

Zemdri

plazomicin

To treat adults with complicated urinary tract infections

Epidiolex

cannabidiol

To treat rare, severe forms of epilepsy

Moxidectin

moxidectin

To treat onchocerciasis due to Onchocerca volvulus in patients aged ≥12 years 

Olumiant

baricitinib

To treat moderately to severely active rheumatoid arthritis

Palynziq

pegvaliase-pqpz

To treat adults with a rare and serious genetic disease known as phenylketonuria 

Doptelet

avatrombopag

To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure

Lokelma

sodium zirconium cyclosilicate

To treat hyperkalemia

Aimovig

erenumab-aooe

For the preventive treatment for migraine

Lucemyra

lofexidine hydrochloride

For the non-opioid treatment for management of opioid withdrawal symptoms in adults

Akynzeo

fosnetupitant and palonosetron

To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Crysvita

burosumab-twza

To treat adults and children aged ≥ 1 year with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets

Tavalisse

fostamatinib

To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)

Ilumya

tildrakizumab

To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Trogarzo

ibalizumab-uiyk

To treat HIV patients who have limited treatment options

Erleada

apalutamide

To treat a certain type of prostate cancer using novel clinical trial endpoint

Symdeko

tezacaftor; ivacaftor

To treat cystic fibrosis in patients aged ≥ 12 years 

Biktarvy

bictegravir, embitcitabine, tenofovir alafenamide

To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen

Lutathera

lutetium Lu 177 dotatate

To treat a type of cancer that affects the pancreas or gastrointestinal tract "gastro-enteropancreatic neuroendocrine tumors" (GEP-NETs)

 

Seven new Biosimilars approved

  • Fulphila(pegfilgrastim-jmdb) and Udenyca (pegfilgrastim-cbqv), respectively the first and second biosimilars to Neulasta
  • Herzuma(trastuzumab-abtr), the second biosimilar to Herceptin
  • Hyrimoz(adalimumab-adaz), the third biosimilar to Humira 
  • Nivestym(filgrastim-aafi), the second biosimilar to Neupogen 
  • Retacrit(epoetin alfa-epbx), the first biosimilar to Epogen/Procrit 
  • Truxima(rituximab-abbs), the first biosimilar to Rituxan

(Source: US FDA, Medscape)

 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

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