59 new drugs approved by US FDA in 2018

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