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February 28, 2019

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:

  • Apomorphine is a sublingual dopamine receptor agonist for the treatment of "off" periods for patients with Parkinson's disease. While other treatments are available, this medication offers quicker onset and unique dosage delivery through the sublingual mucosa.
  • Slinda™ is an oral progestin-only contraceptive that offers fewer episodes of breakthrough bleeding, a lower risk of cardiovascular events and a longer time to take a missed dose of medication than progestin-only alternatives.
  • Zynquista™, the first SGLT1 and SGLT2 inhibitor being developed for the treatment of type 1 diabetes, provides significant control over blood glucose levels and weight reduction, however, there is a potential risk for increased incidences of diabetic ketoacidosis.  

Drug Approvals

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

  • Cablivi® (caplacizumab-yhpd) the first medication in the U.S. specifically indicated for the treatment of adults with the rare blood-clotting disorder thrombotic thrombocytopenic purpura
  • Inbrija™ (levodopa) an orally inhaled treatment for "off" periods in Parkinson's patients
  • Jeuveau™ (praboutulinumtoxina-xvfs) an injectable for the temporary improvement of frown lines, known as glabellar lines
  • Motegrity™ (prucalopride) the first selective serotonin type 4(5-HT4) receptor agonist for the treatment of chronic idiopathic constipation

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:

  • Cabometyx® (cabozantinib) originally indicated for the treatment of renal cell carcinoma, was expanded to treat hepatocellular carcinoma patients previously treated with sorafenib.
  • Lynparza® (olaparib) used for the treatment of BRCA-mutated breast cancer, was expanded to include first-line maintenance therapy of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
  • Nplate® (romiplostim) was expanded from its original indication for thrombocytopenia in patients with chronic immune thrombocytopenic purpura to include pediatric patients with immune thrombocytopenia.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for seizures, atopic dermatitis, and two treatments for chronic obstructive pulmonary disease. 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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