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April 25, 2019

Perspective on the Rx Pipeline

News on an intranasal medication for managing hypoglycemia in type 1 diabetics and more

EnvisionRx continuously monitors the drug pipeline. Our team evaluates changing treatment options in order to educate and inform our clients on the most impactful medications in development, new drugs recently approved, generics being launched and current medications receiving new indications.

Clinical Pipeline

Within the extensive pipeline of drugs preparing for market launch, the three most notable drugs plan sponsors should be aware of are:

  • Nasal Glucagon is an intranasal option for treatment of hypoglycemia in type 1 diabetes patients. If approved, will offer an additional treatment option for managing hypoglycemia.
  • Scenesse® is a dermal implant that stimulates darker pigment production and is being studied for use as a preventative medication for patients with erythropoietic protoporphyria (EPP), which causes painful photosensitivity to the sun. It would provide an unmet need where there are limited therapies.
  • Zolgensma®, a first-in-class biologic single-dose gene replacement, if approved, could provide a treatment alternative for infants and children impacted by the rare disease of spinal muscular atrophy (SMA).  

Drug Approvals

Five drugs recently approved by the Food and Drug Administration (FDA) include:

  • Jatenzo® (testosterone undecanoate) a unique oral formulation of testosterone replacement in men with endocrine disorders
  • Mavenclad® (cladribine) an alternative treatment for both relapsing-remitting and secondary progressive multiple sclerosis with a unique dosing schedule
  • Mayzent® (siponimod) a sphingosine 1-phosphate receptor modulator for the treatment of relapsing-remitting and secondary progressive multiple sclerosis, as well as clinically isolated syndrome
  • Spravato™ (esketamine) an intranasal antidepressant for adults with treatment-resistant depression
  • Zulresso™ (brexanolone) the first medication specifically indicated for the treatment of postpartum depression

The full report also includes a table on biosimilars that have received approval.

New Indications

Drugs that have gained FDA approval for the treatment of additional diseases and/or conditions and have potential to be impactful include:

  • Cimzia® (certolizumab pegol) was expanded to be the first product in the United States approved to treat active non-radiographic axial spondyloarthritis
    (nr-axSpA). Previous indications include a number of inflammatory conditions.
  • Dupixent® (dupilumab) used for the treatment of asthma and atopic dermatitis, was expanded to treat adolescents with moderate-to-severe atopic dermatitis.
  • Soliqua® (insulin glargine/lixisenatide) was expanded to include patients who have uncontrolled type 2 diabetes.
  • Zelnorm® (tegaserod) was approved to be reintroduced into the market for the treatment of irritable bowel syndrome with constipation (IBS-C) in women under 65 years of age after being voluntarily withdrawn in 2007.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for pain and hypertension. A review of generic launches is included in the full report.

Download the full report for more information, including important safety updates and drug shortages and discontinuations.

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