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October 31, 2019

Perspective on the Rx Pipeline

News on development of a preventative treatment for a life-threatening complication of sickle cell disease 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:

  • Crizanlizumab, a monoclonal antibody that works through selectin inhibition, was granted a breakthrough therapy designation from the FDA, as it would potentially help prevent the sometimes life-threatening and incredibly painful vaso-occlusive crises that sickle cell disease patients can suffer. 
  • Lemborexant, a dual orexin receptor antagonist for the treatment of insomnia that showed favorable results when compared directly to other treatment options in clinical trials and could provide another option to safely treat this condition, if approved.
  • Lumateperone, a first-in-class medication for the treatment of schizophrenia that works across three neurotransmitter pathways and could potentially treat both the positive (added to the psyche) and negative (takes away) symptoms of the disease 

Drug Approvals

Seven drugs recently approved by the FDA include:

  • Accrufer™ (ferric maltol), an oral medication for the treatment of iron deficiency in adults that potentially has a more tolerable gastrointestinal profile than other available therapies and could increase adherence. 
  • Nourianz™ (istradefylline), providing a novel mechanism of action for the treatment of "off episodes," or worsening symptoms between treatment, in Parkinson's patients.
  • Rinvoq™ (upadacitinib), an oral medication for the treatment of rheumatoid arthritis in patients who have an intolerance or had an inadequate response to methotrexate.
  • Rozlytrek™ (entrectinib), the second approved treatment option for neurotrophic tyrosine receptor kinase (NTRK) gene fusion tumors. It also treats non-small cell lung cancer.
  • Rybelsus® (semaglutide), the first approved oral glucagon-like polypeptide (GLP-1) agonist in the U.S. for the treatment of type 2 diabetes.
  • Turalio™ (pexidartinib), approved to treat the rare condition of tenosynovial giant cell tumor (TGCT), providing an option for those with recurrent TCGT or who are unable to be treated with surgery. 
  • Wakix® (pitolisant hydrochloride), the first non-scheduled substance for the treatment of daytime sleepiness in narcolepsy patients.

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:

  • Descovy® (emtricitabine and tenofovir alafenamide), expanded to be the second medication with an indication to provide pre-exposure prophylaxis (PrEP) to prevent HIV.
  • Invokana® (canagliflozin), expanded to treat diabetic kidney disease (DKD), making it the only medication indicated to treat or reduce the risk of both DKD and heart failure in type 2 diabetes patients.
  • Ofev® (nintedanib), first indicated to treat idiopathic pulmonary fibrosis, now is also approved to slow the rate of decline in pulmonary function for patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
  • Rituxan® (rituximab), expanded from its designation to treat adults to include pediatric patients with granulomatosis with polyangiitis (GPA) or Wegener's Granulomatosis and microscopic polyangiitis (MPA).
  • Taltz® (ixekizumab), for the treatment of plaque psoriasis and psoriatic arthritis was also approved to treat ankylosing spondylitis (AS).

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for the prevention of chemotherapy-induced vomiting and preparation for a colonoscopy. 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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