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Perspective on the Rx Pipeline: A Summary of Impactful Changes

August 28, 2018

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 four most notable drugs plan sponsors should be aware of are:

  • Baloxavir marboxil inhibits an enzyme required for viral replication in influenza, providing a unique mechanism of action against influenza A and B viruses, including avian strains (H7N9, H5N1) and strains that are resistant to oseltamivir. As a single dose regimen, baloxavir would be different from the currently available products on the market.
  • Cladribine is an immunomodulatory therapy that effects T cells and B cells, which leads to a decrease in levels of inflammation in multiple sclerosis (MS) patients. Already available in 38 countries, cladribine could offer a cost-effective treatment option for rapidly evolving severe and suboptimally treated relapsing-remitting MS, with a unique mechanism of action in an oral dosage form and a short treatment course of eight to 20 days per year.
  • Dacomitinib for the treatment of locally advanced or metastatic non-small cell lung cancer, has shown significant, clinically meaningful improvement in progression free survival rates over medications currently in the market, although it appears to have greater toxicity.
  • Galcanezumab has the potential to be the third approval in the new calcitonin gene-related peptide (CGRP) therapeutic class for the prevention of migraines. It will offer a once monthly subcutaneous dosing.

Drug Approvals

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

  • Braftovi™/ Mektovi® (encorafenib/binimetinib) for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutation
  • Galafold™ (migalastat) treats a rare genetic disorder known as Fabry disease
  • Krintafel™ (tafenoquine) for the treatment of plasmodium vivax malaria for patients age 16 or older
  • Orilissa™ (elagolix sodium) treats moderate to severe pain caused by endometriosis in women 18 years of age or older
  • Tpoxx® (tecovirimat) treats smallpox caused by variola virus in adults and pediatric patients

New Indications

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

  • Cinryze® (C1 esterase inhibitor) developed to prevent swelling attacks in adult patients with hereditary angioedema, was expanded to treat children and teenagers on June 10, 2018.
  • Xtandi® (enzalutamide) was first approved for the treatment of castration-resistant prostate cancer (CRPC) in patients who received docetaxel. Later it was expanded to treat chemotherapy naïve CRPC patients and on July 13, 2018, it received approval to include men with non-metastatic CRPC.

Generic Approvals

There are several new generic product offerings to the marketplace, including a drug for opioid use disorder, two medications for the treatment of ulcerative colitis, a drug for scabies and a treatment for osteoarthritis. A glimpse into the potential generic launches is included in the full report.

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