Traditional Pipeline

<< Drug Pipeline Review

Last updated: 07.20.21

DRUG NAME/ MANUFACTURER PROPOSED USE HOW IT WORKS WHAT’S IMPORTANT
ansofaxine (Luye Pharma) major depressive disorder A pro-drug of desvenlafaxine formulated as a sustained-release tablet; ansofaxine is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor (SNRI). Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: An estimated 17.3 million adults in the United States had at least one major depressive episode, representing about 7% of all U.S. adults. An additional 3.2 million adolescents, aged 12 to 17, in the United States had at least one major depressive episode. This number represented 13.3% of the U.S. population aged 12 to 17.
atogepant (Allergan) migraine headaches CGRP receptor antagonist for preventive treatment of migraines without aura in adults who meet the criteria for episodic migraine. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 3Q2021
Impact: Migraine affects approximately 12% of US adults, or about 39 million Americans.
It is estimated that approximately 3.5 million patients in the U.S. use medications that prevent/reduce migraine frequency/severity.  The oral CGRP antagonists could achieve $4 billion in sales in migraine prevention alone.
budesonide oral suspension (Eohilia - Takeda) localized esophageal inflammation caused by eosinophilic esophagitis (EoE) Topically active, oral viscous formulation of budesonide (topical corticosteroid) for improving esophageal eosinophil counts and endoscopic findings in adults with a new diagnosis of EoE. Route of administration: Topical/Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: Mid 2021
Impact: Shire estimates 150,000 patients
in the U.S. are impacted by EoE annually.
bupropion/dextromethorphan (Axsome) major depressive disorder Dextromethorphan is an N-Methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion is a norepinephrine and dopamine reuptake inhibitor and a nicotinic acetylcholine receptor antagonist.
Bupropion, as a cytochrome CYP2D6 inhibitor, also increases the bioavailability of dextromethorphan. Ultimately, this
combination product combines the mechanisms of action of several distinct antidepressant therapeutic classes into
one therapeutic agent.
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: August 2021
Impact: According to the National Institutes of Health, an estimated 7.1% of U.S. adults, or approximately 17 million, experience MDD each year. Nearly two thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy, highlighting the need for additional therapies with new mechanisms of action.
daridorexant (Idorsia) insomnia Dual orexin receptor antagonist (DORA) for the treatment of insomnia. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: January 2022
Impact: Approximately 30% of adults report one or more symptoms of insomnia including difficulty initiating and/or maintaining sleep.
dihydroergotamine mesylate
(Trudhesa - Impel NeuroPharma)
migraine  Dihydroergotamine mesylate for the acute treatment of migraine headaches with or without aura in adult patients; dihydroergotamine mesylate (DHE) acts centrally, decreasing vascular tone and slowing the heart rate, as well as peripherally, to block alpha-receptors for the treatment of migranes. Route of administration: Intranasal
Benefit coverage: Pharmacy
Anticipated FDA decision: September 2021
Impact: migraine affects approximately 12% of US adults, or about 39 million Americans.
donepezil transdermal system
(Adlarity - Corium)
dementia Once-weekly patch formulation of donepezil (a cholinesterase inhibitor) for treatment of dementia of the Alzheimer's type. Route of administration: Transdermal
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Alzheimer’s disease is the most common form of dementia, affecting 5.8 million Americans over the age of 65, as well as hundreds of thousands under the age of 65 who have early-onset Alzheimer’s.
eflornithine/sulindac (Cancer
Prevention Pharmaceuticals)
familial adenomatous polyposis
(FAP)
Combination of the ornithine decarboxylase inhibitor and the non-steroidal anti-inflammatory drug, sulindac, for pharmaco-preventive treatment of adults with FAP; eflornithine, an ornithine decarboxylase inhibitor, may help prevent colorectal cancer by disrupting the polyamine synthesis pathway, a molecular pathway that is thought to be important in the development of colorectal and other cancers. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: Mid 2021
Impact: Familial adenomatous polyposis (FAP) occurs in approximately one in 5,000 to 10,000 individuals in the United States and accounts for about 0.5% of all cases of colorectal cancer.
finerenone (Bayer) diabetic kidney disease Oral mineralocorticoid receptor antagonist (MRA) for treating diabetic kidney disease; It works by blocking the effects of hormones (such as aldosterone and cortisol), which can cause damage to the heart and kidneys in diabetic patients. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: July 2021
Impact: Chronic kidney disease (CKD) is one of the most frequent complications arising from diabetes. It is also an independent risk factor for cardiovascular disease. Approximately 40% of all patients with type 2 diabetes develop chronic kidney disease. More than 35% of people aged 20 years or older with diabetes have chronic kidney disease. It is estimated that CKD affects more than 160 million people with T2D worldwide.
gefapixant (MK-7264 - Merck) refractory chronic cough (RCC) or unexplained chronic cough
(UCC)
Selective P2X3 receptor antagonist for the treatment RCC or UCC in adults; It is believed that excessive activation of P2X3 receptors is associated with hyper-sensitization of sensory neurons; neuronal hyper-sensitization in the airways and lungs, triggered by injury or infection, can cause an exaggerated, persistent and frequent urge to cough. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: December 2021
Impact: The prevalence of chronic cough (a cough lasting more than 8 weeks) is estimated at 10% of the general adult population globally, and in up to 46% of these cases, no treatable cause can be identified.
insulin aspart biosimilar Kixelle - Viatris) diabetes Biosimilar formulation of rapid-acting insulin aspart (NovoLog). Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: July 2021
Impact: According to the U.S. Centers for Disease Control and Prevention (CDC), about 30 million Americans have diabetes. Of them, approximately 6 million use insulin.
insulin glargine (Semglee -
Mylan/Biocon)
diabetes to allow interchangeability with Sanofi's long-acting insulin, Lantus Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision:August 2021
Impact: An estimated 22.5 million adults will be diagnosed with type 2 diabetes. In the US, basal insulin market is estimated at more than $6 billion.
mavacamten (Bristol Myers Squibb) obstructive hypertrophic cardiomyopathy (oHCM) cardiac myosin modulator for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: January 2022
Impact:  HCM is estimated to affect one in every 500 people. There are currently approximately 160,000 to 200,000 people diagnosed with symptomatic obstructive HCM across the U.S. and EU, with no existing effective drug treatment options beyond limited symptomatic relief.
naloxone injection (Zimhi - Adamis) opioid overdose Higher dose of naloxone, an opioid antagonist, formulated in a prefilled syringe for injection to treat an opioid overdose;  Route of administration: Intramuscular
Benefit coverage: Pharmacy
Anticipated FDA decision: November 2021
Impact:  According to statistics published by the U.S. Centers for Disease Control and Prevention (CDC), in 2017, drug overdoses resulted in approximately 72,000 deaths in the U.S. – greater than 195 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50 and the proliferation of more powerful synthetic opioids, like fentanyl and its analogues, could result in future increases in the number of deaths resulting from opioid overdoses.
pilocarpine 1.25% (Presbysol - Allergan) presbyopia Optimized formulation of pilocarpine, a cholinergic muscarinic receptor agonist, for the treatment of presbyopia or farsightedness caused by loss of elasticity of the lens of the eye, occurring typically in middle and old age Route of administration: Ophthalmic
Benefit coverage: Pharmacy
Anticipated FDA decision: October 2021
Impact: Presbyopia is a common, progressive condition that reduces the aging eye's ability to focus on near objects and affects nearly half of the adult U.S. population, or about 128 million adults. It is a common and progressive eye condition that reduces the eye's ability to focus on near objects and usually impacts people after age 40. Worldwide, as many as 2 billion are affected by presbyopia.
pneumococcal vaccine, 15-valent
(V114 - Merck)
pneumococcal conjugate vaccine A 15-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease in adults aged 18 years of age and older. Route of administration: Intramuscular
Benefit coverage: Pharmacy
Anticipated FDA decision: July 2021
Impact: Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually.
tadalafil / finasteride (Tadfin - Veru) benign prostatic hyperplasia (BPH) Combination of tadalafil (5mg) and finasteride (5mg) for treating benign prostatic hyperplasia (BPH); Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor and finasteride is a Type 2, 5 alpha reductase inhibitor; these drugs are currently indicated for co-administration, as separate products, for the initial treatment of BPH for up to 26 weeks. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: December 2021
Impact: This is a very large market, impacting up to 25% of the male population, at an estimated 1.1 billion males worldwide (2018).  The worldwide prevalence of BPH lower urinary symptoms is estimated to be 10-25% of the male population.
testosterone undecanoate (Kyzatrex -
Marius Pharmaceuticals)
hypogonadism Soft gelatin capsule formulation of the testosterone replacement therapy for treatment of primary and secondary
hypogonadism in adult men.
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: October 2021
Impact: An estimated 15 million men in the U.S. suffer from hypogonadism, but only approximately 10% are currently treated.
topiramate oral solution (Eton Pharmaceuticals) seizure disorders Liquid formulation of topiramate as monotherapy for the treatment of partial-onset or primary general tonic-clonic
seizures in pediatric patients aged 2 years and older; for adjunctive therapy for partial-onset seizures, including Lennox-Gastaut syndrome, in patients aged 2 yrs and up; and for preventative treatment of migraine in patients 12 yrs and older.
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: August 2021
Impact: In 2018, topiramate products had annual sales of approximately $800 million.

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