Anthem Blue Cross and Blue Shield (Anthem) reviews the activities of the 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:

 

 

New molecular entities approvals — January to 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

 

 

 

 

 

July 24, 2020

Head lice

Amisulpride

Barhemys

X

 

 

 

 

 

February 26, 2020

Postoperative nausea and vomiting

Avapritinib

Ayvakit

 

X

X

X

X

 

January 9, 2020

PDGFRa exon 18 mutant gastrointestinal stromal tumor

Belantamab mafodotin

Blenrep

 

 

 X

X

X

X

August 5, 2020

Multiple myeloma

Bempedoic acid

Nexletol

X

 

 

 

 

 

February 21, 2020

Dyslipidemia

Brexucabtagene autoleucel

Tecartus

 

 

X

X

X

X

July 24, 2020

Mantle cell lymphoma

Capmatinib

Tabrecta

 

 

X

X

X

X

May 6, 2020

Non-small cell lung cancer (NSCLC)

Decitabine/ cedazuridine

Inqovi

 

 

X

 

X

 

July 7, 2020

Myelodysplastic syndromes

Eptinezumab-jjmr

Vyepti

X

 

 

 

 

 

February 21, 2020

Migraine prevention

Fostemsavir

Rukobia

 

X

X

X

 

 

July 2, 20202

HIV treatment

Inebilizumab

Uplizna

X

 

 

X

X

 

June 11, 2020

Neuromyelitis optica spectrum disorder

Isatuximab

Sarclisa

X

 

 

 

X

 

March 2, 2020

Multiple myeloma

Lurbinectedin

Zepzelca

 

 

X

 

X

X

June 15, 2020

NSCLC

Nifurtimox

Lampit

 

 

X

 

X

X

August 6, 2020

Chagas disease

Oliceridine

Olinvyk

X

X

 

 

 

 

August 7, 2020

Moderate to severe acute pain

Opicapone

Ongentys

X

 

 

 

 

 

April 24, 2020

Parkinson’s disease

Osilodrostat

Isturisa

X

 

 

 

X

 

March 6, 2020

Cushing’s disease

Ozanimod

Zeposia

X

 

 

 

 

 

March 25, 2020

Multiple sclerosis

Peanut (Arachis hypogaea) allergen powder-dnfp

Palforzia

X

X

 

X

 

 

January 31, 2020

Peanut allergy

Pemigatinib

Pemazyre

 

 

X

X

X

X

April 17, 2020

Cholangiocarcinoma

Remimazolam

Byfavo

X

 

 

 

 

 

April 2, 20202

Sedation for procedures

Rimegepant

Nurtec ODT

 

 

X

 

 

 

February 27, 2020

Migraine treatment

Risdiplam

Evrysdi

 

X

X

X

X

 

August 7, 2020

Spinal muscular atrophy

Ripretinib

Qinlock

 

X

X

X

X

 

May 15, 2020

Gastrointestinal stromal tumor

Sacituzumab-hziy

Trodelvy

 

X

X

X

X

X

April 22, 2020

Triple negative breast cancer

Selpercatinib

Retevmo

 

 

X

X

X

X

May 8, 2020

NSCLC and thyroid cancers

Selumetinib

Koselugo

 

X

X

X

X

 

April 10, 2020

Neurofibromatosis type 1

Tafasitamab

Monjuvi

X

X

 

X

X

X

July 31, 2020

Large B-cell lymphoma

Tazemetostat

Tazverik

 

 

X

 

X

X

January 23, 2020

Epithelioid sarcoma

Teprotumumab-trbw

Tepezza

 

X

X

X

X

 

January 21, 2020

Thyroid eye disease

Triheptanoin

Dojolvi

X

X

 

 

X

 

June 30, 2020

Long-chain fatty acid oxidation disorders

Tucatinib

Tukysa

 

X

X

X

X

 

April 17, 2020

Breast cancer

Viltolarsen

Viltepso

 

X

X

 

X

X

August 12, 2020

Duchenne muscular dystrophy

 

Source: fda.gov

 

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Featured In:
November 2020 Anthem Provider News - Wisconsin