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November 8, 2018

Perspective on the Rx Pipeline: A Summary of Impactful Changes

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:

  • Brexanolone a GABA-A modulator for the treatment of postpartum depression that would offer the first FDA-approved treatment for this condition. While clinical trials have shown a rapid and durable reduction in depression symptoms, additional data will be needed in regards to sustained improvement.
  • Emapalumab a fully human monoclonal antibody being investigated for the treatment of hemophagocytic lymphohistiocytosis (HLH), a potentially fatal orphan disease. If approved, it could offer an innovative target and potentially less toxic approach than conventional therapy.
  • Ravulizumab for the treatment of the rare, debilitating and potentially fatal disease paroxysmal nocturnal hemoglobinuria, is a longer acting, anti-C5 antibody that could allow for less frequent dosing than the currently available treatment. 

Drug Approvals

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

  • Ajovy™ (fremanezumab-vfm) the second drug in a new class of medications known as calcitonin gene-related peptide (CGRP) inhibitors for the prevention of migraines
  • Emgality™ (galcanezumab-gnlm) another CGRP inhibitor that received approval for migraine prophylaxis
  • Libtayo® (cemiplimab-rwlc) for the treatment of locally advanced metastatic cutaneous squamous cell carcinoma
  • Takhzyro™ (lanadelumab-flyo) a therapy used to prevent hereditary angioedema attacks

New Indications

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

  • Fycompa™ (perampanel) developed for the treatment of partial-onset seizures in adults was expanded to treat children age four and older on September 28, 2018.
  • Gardasil® 9 (human papillomavirus 9-valent vaccine recombinant) is a vaccine to prevent certain cancers caused by the human papillomavirus and the FDA broadened the age range of patients who can receive it on October 5, 2018.
  • Hemlibra® (emicizumab-kxwh) prevents or reduces the frequency of bleeding episodes in patients with hemophilia A. On October 4, 2018, the FDA expanded the indication to include hemophilia patients without factor VIII inhibitors.
  • Imbruvica® (ibrutinib) approved as a monotherapy was expanded in combination with rituximab for the treatment of the rare blood cancer Waldenström’s macroglobulinemia.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for multiple sclerosis, attention deficit disorder and erectile dysfunction. 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.

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