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Perspective on the Rx Pipeline

February 27, 2020

News on the approval of the first medication for the mitigation of reactions associated with peanut allergies 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, these are the three most notable drugs plan sponsors should be aware of:

  • Amphora®, a multi-purpose vaginal pH regulator (MVP-R™) for contraception. If approved, this contraceptive would offer a non-hormonal option that can be used as needed and may help address antimicrobial drug resistance.
  • Ozanimod, a sphingosine-1-phosphate receptor modulator for the treatment of relapsing-remitting multiple sclerosis (RRMS) that may offer a potentially better side effect profile than others on the market. Ozanimod is also applying for indications to treat ulcerative colitis and Crohn's disease, offering a new mechanism of action to manage these conditions. 
  • Risdiplam, a gene splicing modifier intended to increase survival motor neuron protein levels for those with spinal muscular atrophy (SMA). The treatment received fast track designation and, ultimately, priority review status from the FDA. If approved, it would offer an oral treatment option for this orphan disease 

Drug Approvals

Eight drugs recently approved by the FDA include:

  • Dayvigo™ (lemborexant), an oral medication for the treatment of insomnia. Notably, it was found to be well tolerated by patients 55 years of age and older, a population at increased risk for side effects from insomnia medications. 
  • Givlaari™ (givosiran), the first FDA-approved product for the prevention of acute porphyria attacks in adults.
  • Oxbryta™ (voxelotor), a first-in-class treatment for sickle cell disease that increases hemoglobin levels and reduces markers of hemolysis.
  • Padcev™ (enfortumab vedotin), a treatment option for locally advanced or metastatic urothelial cancer in adults who previously received other treatments.
  • Palforzia™ (peanut [arachis hypogaea] allergen powder-dnfp), the first immunotherapy medication approved for the mitigation of reactions associated with peanut allergies.
  • Tepezza (teprotumumab-trbw), an intravenous infusion treatment option for the rare condition of thyroid eye disease. 
  • Ubrelvy™ (ubrogepant), the first oral calcitonin gene-related peptide (CGRP) antagonist approved for the relief of acute migraine symptoms.
  • Vyondys 53 (golodirsen), a treatment option for patients with duchenne muscular dystrophy that are exon 53 mutation amenable.

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:

  • Lynparza® (olaparib), approved for the additional indication of maintenance treatment of adult patients with certain forms of pancreatic cancer.
  • Vascepa® (icosapent ethyl), expanded to reduce the risk of cardiovascular death and events in patients with hypertriglyceridemia in conjunction with statin therapy.
  • Xeljanx XR® (tofacitinib), first indicated to treat rheumatoid and psoriatic arthritis was approved for the additional indication of ulcerative colitis.
  • Xtandi® (enzalutamide), approved for the additional indication of metastatic castration-sensitive prostate cancer.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for the treatment of diabetes, an opioid overdose and pregnancy prevention. 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.