FDA approvals and expedited pathways used: New molecular entities (NMEs)

Please note, this communication applies to Anthem HealthKeepers Plus offered by HealthKeepers, Inc.

 

HealthKeepers, Inc. 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 our providers and members.

 

The FDA approves new drugs and biologics using various pathways. Recent studies on the effectiveness of drugs and biologics going through 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. Follow this link to learn more about the standard review process.

 

• 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. Follow this link to learn more about the fast track process.

 

• Priority review —A priority review designation means FDA’s goal is to take action on an application within six months. Follow this link to learn more about the priority review process.

 

• Breakthrough therapy — This process is designed to expedite the development and review of drugs/biologics which may demonstrate substantial improvement over available therapy. Follow this link to learn more about the breakthrough therapy review process.

 

• Orphan review — This refers to the review of drugs that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Follow this link to learn more about the orphan drug review process.

 

 

• 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, follow this link.

 

New molecular entities approvals: January 2020 through 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.

 

HealthKeepers, Inc. 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.

 

Note: This information has no impact on our standard prior authorization/pre-certification process.

 

 

Generic name	Trade name	Standard review	Fast track	Priority	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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