FDA approvals and expedited pathways used -- New Molecular Entities (NMEs)

Anthem Blue Cross and Blue Shield (Anthem) reviews the activities of the Food and Drug Administration (FDA)’s approval of drugs and biologics on a regular basis to understand the potential effects for both our providers and members.

 

The FDA approves new drugs/biologics using various pathways of approval. Recent studies on the effectiveness of drugs/biologics going through these different FDA pathways illustrates the importance of clinicians being aware of the clinical data behind a drug or biologic approval in making informed decisions.

 

Here is a list of the approval pathways the FDA uses for drugs/biologics:

 

• Standard Review – The Standard review process follows well-established paths to make sure drugs/biologics are safe and effective when they reach the public. From concept to approval and beyond, FDA performs these steps: reviews research data and information about drugs and biologics before they become available to the public; watches for problems once drugs and biologics are available to the public; monitors drug/biologic information and advertising; and protects drug/biologic quality. To learn more about the Standard Review process, click here.

• Fast Track – Fast Track is a process designed to facilitate the development, and expedite the review of drugs/biologics to treat serious conditions and fill an unmet medical need. To learn more about the Fast Track process, click here.
• Priority Review – A Priority Review designation means FDA’s goal is to take action on an application within 6 months. To learn more about the Priority Review process, click here.
• Breakthrough Therapy – A process designed to expedite the development and review of drugs/biologics which may demonstrate substantial improvement over available therapy. To learn more about the Breakthrough Therapy process, click here.
• Orphan Review – Orphan Review is the evaluation and development of drugs/biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. To learn more about the Orphan Review process, click here.
• Accelerated Approval – These regulations allowed drugs/biologics for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. To learn more about the Accelerated Approval process, click here.

 

New Molecular Entities Approvals: January - August 2020

 

Certain drugs/biologics are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active ingredients that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.

 

Anthem reviews the FDA-approved NMEs on a regular basis. To facilitate the decision-making process, we are providing a list of NMEs approved from January to August 2020 along with the FDA approval pathway utilized.

 

Generic Name	Trade Name	Standard Review	Fast Track	Priority Review	Break-through Therapy	Orphan Review	Accelerated Approval	Approval Date	Indication
Abametapir	Xeglyze	X						7/24/2020	Head lice
Amisulpride	Barhemys	X						2/26/2020	Postoperative nausea and vomiting
Avapritinib	Ayvakit		X	X	X	X		1/9/2020	PDGFRa exon 18 mutant gastrointestinal stromal tumor
Belantamab mafodotin	Blenrep			X	X	X	X	8/05/2020	Multiple myeloma
Bempedoic acid	Nexletol	X						2/21/2020	Dyslipidemia
Brexucabtagene autoleucel	Tecartus			X	X	X	X	7/24/2020	Mantle cell lymphoma
Capmatinib	Tabrecta			X	X	X	X	5/6/2020	Non-small cell lung cancer (NSCLC)
Decitabine/ cedazuridine	Inqovi			X		X		7/07/2020	Myelodysplastic syndromes
Eptinezumab-jjmr	Vyepti	X						2/21/2020	Migraine prevention
Fostemsavir	Rukobia		X	X	X			7/02/2020	Human immunodeficiency virus (HIV) treatment
Inebilizumab	Uplizna	X			X	X		6/11/2020	Neuromyelitis optica spectrum disorder
Isatuximab	Sarclisa	X				X		3/2/2020	Multiple myeloma
Lurbinectedin	Zepzelca			X		X	X	6/15/2020	NSCLC
Nifurtimox	Lampit			X		X	X	8/06/2020	Chagas disease
Oliceridine	Olinvyk	X	X					8/07/2020	Moderate to severe acute pain
Opicapone	Ongentys	X						4/24/2020	Parkinson’s disease
Osilodrostat	Isturisa	X				X		3/6/2020	Cushing’s disease
Ozanimod	Zeposia	X						3/25/2020	Multiple sclerosis
Peanut (Arachis hypogaea) allergen powder-dnfp	Palforzia	X	X		X			1/31/2020	Peanut allergy
Pemigatinib	Pemazyre			X	X	X	X	4/17/2020	Cholangiocarcinoma
Remimazolam	Byfavo	X						7/02/2020	Sedation for procedures
Rimegepant	Nurtec ODT			X				2/27/2020	Migraine treatment
Risdiplam	Evrysdi		X	X	X	X		8/07/2020	Spinal muscular atrophy
Ripretinib	Qinlock		X	X	X	X		5/15/2020	Gastrointestinal stromal tumor
Sacituzumab-hziy	Trodelvy		X	X	X	X	X	4/22/2020	Triple negative breast cancer
Selpercatinib	Retevmo			X	X	X	X	5/8/2020	NSCLC and thyroid cancers
Selumetinib	Koselugo		X	X	X	X		4/10/2020	Neurofibromatosis type 1
Tafasitamab	Monjuvi	X	X		X	X	X	7/31/2020	Large B-cell lymphoma
Tazemetostat	Tazverik			X		X	X	1/23/2020	Epithelioid sarcoma
Teprotumumab-trbw	Tepezza		X	X	X	X		1/21/2020	Thyroid eye disease
Triheptanoin	Dojolvi	X	X			X		6/30/2020	Long-chain fatty acid oxidation disorders
Tucatinib	Tukysa		X	X	X	X		4/17/2020	Breast cancer
Viltolarsen	Viltepso		X	X		X	X	8/12/2020	Duchenne muscular dystrophy

 

Source: www.fda.gov

 

 

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