Traditional Pipeline

<< Drug Pipeline Review

Last updated: 05.10.22

DRUG NAME/ MANUFACTURER PROPOSED USE HOW IT WORKS WHAT’S IMPORTANT
ansofaxine (Luye Pharma) major depressive disorder Ansofaxine is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor (SNRI), desvenlafaxine.  Reuptake inhibitors work to increase the concentration of neurotransmitters in the brain, such as serotonin and norepinephrine, that regulate mood. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 4Q2022
Impact: An estimated 17.3 million adults in the United States have 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 have had at least one major depressive episode. This number represents 13.3% of the U.S. population aged 12 to 17.
bupropion/dextromethorphan (Axsome) major depressive disorder Dextromethorphan is a 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: 2022
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.
elacestrant (Menarini Group) metastatic breast cancer Elacestrant is a selective estrogen receptor down-regulator/degrader (SERD) for treatment of estrogen receptor (ER)-positive/HER2-negative metastatic breast cancers that progressed on prior endocrine and targeted therapies. Elacestrant interferes with the activity of estrogen on breast cancer cells by attaching to estrogen receptors and causing them to degrade. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 4Q2022
Impact: HR+/HER2- is the most common subtype with an age-adjusted rate of 88.1 new cases per 100,000 women. This subtype occurs in about 68 percent of all breast cancers. 
insulin aspart biosimilar (Kixelle - Viatris) diabetes Kixelle is a biosimilar formulation of NovoLog (insulin aspart), rapid-acting insulin. Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: 2023
Impact: According to the CDC, about 30 million Americans have diabetes. Of them, approximately 6 million use insulin.
linzagolix (Yselty - ObsEva) endometriosis and uterine fibroids Linzagolix is a gonadotropin-releasing hormone (GnRH) antagonist for the treatment of endometriosis and uterine fibroids.  It decreases estrogen in the body which is helpful in the treatment of estrogen-dependent diseases such as endometriosis and uterine fibroids. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 3Q2022
Impact: Endometriosis is a common disorder estimated to affect about one in 10 women in their reproductive years, or about 6.5 million women. Uterine fibroids are the most common benign tumor in women.
mavacamten (Bristol Myers Squibb) obstructive hypertrophic cardiomyopathy (oHCM) Mavacamten is a cardiac myosin modulator for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM).  It inhibits the activity of the proteins involved in muscle contraction decreasing contractility of the heart muscle to offset the hypercontractility in oHCM.  Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2Q2022
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.
meloxicam / rizatriptan (Axsome) acute migraine Fixed-dose combination of MoSEIC meloxicam, a rapidly absorbed formulation of the NSAID, and rizatriptan for the acute treatment of migraine.  NSAIDs are useful in migraine treatment due to their analgesic effects and because they block the production of inflammatory prostaglandins.  Triptans counteract the painful vasodilation that occurs with migraines.  Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2Q2022
Impact:  A significant portion of the nearly 40 million migraine sufferers in the U.S. report an inadequate response to current acute treatments.
NVX-CoV2373 (Nuvaxovid - Novavax) SARS-CoV-2 Vaccine Nuvaxovid is a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine for the prevention of COVID-19.  It is a protein-based vaccine created from the genetic sequence of the original SARS-CoV-2 strain.  It also contains a proprietary adjuvant to increase immune response and antibody formation. Route of administration: Intramuscular
Benefit coverage: Pharmacy and Medical
Anticipated FDA decision: First Half of 2022
Impact:  According to the most recent CDC tracker (04/12/2022; https://covid.cdc.gov/covid-data-tracker/#cases_casesinlast7days), more than 80.2 million cases of COVID-19 infections have been identified since the beginning of the pandemic and have resulted in more than 982,809 deaths.
nirmatrelvir/ritonavir (Paxlovid - Pfizer) mild-to-moderate COVID-19 in those at risk for progressing to severe COVID-19 and/or hospitalization Nirmatrelvir is a type of antiviral known as a protease inhibitor.  It possesses activity against coronaviruses and is packaged with a low dose of ritonavir, another protease inhibitor that blocks the metabolism of nirmatrelvir to maintain its concentration in the body at a therapeutic level.  Paxlovid was granted an Emergency Use Authorization in December of 2021 and is expected to receive full FDA approval in 2022. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2022
Impact:  According to the most recent CDC tracker (04/12/2022; https://covid.cdc.gov/covid-data-tracker/#cases_casesinlast7days), more than 80.2 million cases of COVID-19 infections have been identified since the beginning of the pandemic and have resulted in more than 982,809 deaths.
omecamtiv mecarbil (Cytokinetics)  chronic heart failure with reduced ejection fraction (HFrEF) Omecamtiv mecarbil is a novel cardiac myosin activator for the treatment of chronic heart failure. It activates proteins involved in cardiac muscle contraction increasing the force of these contractions and the ability of the heart to eject blood. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 4Q2022
Impact:  In the U.S., 6.5 million people have heart failure, and approximately 40-50% of these patients have HFrEF.  Annually, approximately 30% of patients with symptomatic chronic heart failure will experience worsening of the disease.  One in five patients with worsening chronic HFrEF will die within two years.
roflumilast cream (Arcutis Biotherapeutics) mild-to-moderate plaque psoriasis Roflumilast cream is a topical PDE4 inhibitor for the treatment of mild-to-moderate plaque psoriasis.  PDE4 is an enzyme that works to regulate skin inflammation and blocking its effects is useful in inflammatory skin conditions.  An oral form of roflumilast, Daliresp, is approved to treat COPD. Route of administration: Topical
Benefit coverage: Pharmacy
Anticipated FDA decision: 3Q2022
Impact: Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 3% of the U.S. population, affecting approximately 8.6 million individuals in the U.S.
tapinarof cream mild-to-moderate plaque psoriasis Tapinarof is an aryl hydrocarbon receptor modulating agent for the treatment of mild-to-moderate plaque psoriasis.  Aryl hydrocarbon receptors are chemical sensors that mediate cells' responses to substances in the environment, including inflammation.  Tapinarof blocks inflammation, which can lead to psoriasis, and is an antioxdant. Route of administration: Topical
Benefit coverage: Pharmacy
Anticipated FDA decision: 2Q2022
Impact: Plaque psoriasis, which affects approximately eight million patients in the U.S., is characterized by itchy, red, scaly patches on the skin. Moderate-to-severe plaque psoriasis accounts for nearly 35% of psoriasis cases.
tirzepatide (Lilly) type 2 diabetes Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.  GIP and GLP-1 are hormones which are both secreted from the intestine to stimulate insulin secretion in response to ingested food.  Tirzepatide mimics their effect in the body to increase available insulin. Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: 2Q22
Impact: Approximately 34 million Americans (just over 1 in 10) have diabetes. Type 2 diabetes is the most common type accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone. Tirzepatide is a potential blockbuster medication with 2026 sales estimated at $4.8 billion
vonoprazan (Takecab - Phathom Pharmaceuticals) gastric acid suppression; Helicobacter pylori (H. pylori) infection Vonoprazan is a potassium-competitive acid blocker that blocks the production and secretion of stomach acid for use in combination with amoxicillin and clarithromycin for the treatment of H. pylori infection. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2Q22
Impact: H.  pylori infections of the stomach lining can cause chronic inflammation, ulcers, and gastric cancer. Eradication of H. pylori in is recommended to prevent these complications.  
zavegepant (Biohaven) migraine headaches Zavegepant is a CGRP receptor antagonist for the acute treatment of migraine. CGRP is thought to be involved in several mechanisms causing migraine pain, including dilation of blood vessels, release of inflammatory chemicals, and pain signaling.  Blocking the action CGRP can relieve migraine pain. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2023
Impact: Migraine affects approximately 12% of US adults, or about 40 million Americans. In adults, the incidence is three times more common in women than men.
zuranolone (Sage Therapeutics) major depressive disorder Zuranolone is a next-generation GABA modulator for the treatment of moderate to severe major depressive disorder (MDD).  GABA is a calming neurotransmitter.  Various conditions, such as depression and anxiety, are associated with low GABA levels. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2023
Impact: Major depressive disorder affects approximately 19 million people in the U.S. Also, in the U.S., there are more than 41,000 suicides each year, many of which result from untreated or poorly treated major depression. It is estimated that only 30 percent of patients on currently available antidepressants achieve remission. As a result, additional treatment options are needed to help those suffering from this condition.

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