subscribe now
Not getting email updates?

Perspective on the Rx Pipeline: A Summary of Impactful Changes

December 19, 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 three most notable drugs plan sponsors should be aware of are:

  • Evenity, an investigational bone-forming monoclonal antibody designed to work by inhibiting the activity of sclerostin, increasing bone formation and reducing bone resorption, offers an injectable option for patients with a high risk of fractures due to postmenopausal osteoporosis. 
  • Rekynda offers a novel mechanism of action, allowing the brain pathways to modulate sexual response, in premenopausal women with hypoactive sexual desire disorder. If approved, it would provide an additional treatment option with less potential for drug or alcohol interactions.
  • Siponimod is a selective modulator of specific types of the sphingosine-1-phosphate receptor found to reduce the risk of disability progression in patients that have relapsing-remitting multiple sclerosis that has progressed to secondary progressive MS. If approved, it would offer an oral disease modifying therapy option compared to other mainly injectable products available.  

Drug Approvals

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

  • Lorbrena® (lorlatinib) for patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer whose disease has progressed on specific
    prior treatment
  • Udenyca™ (pegfilgrastim-cbqv) indicated to decrease the incidence of febrile neutropenia infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs
  • Vitrakvi® (larotrectinib) the first treatment for cancers that express the neurotrophic receptor tyrosine kinase (NTRK) mutation
  • Xofluza™ (baloxivir marboxil) for the treatment of acute uncomplicated influenza
    in patients 12 years of age or older who have been symptomatic for no more than
    48 hours
  • Yupelri™ (revefenacin) a maintenance treatment for chronic obstructive pulmonary disease (COPD)

New Indications

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

  • Adcetris® (brentuximab vedotin) originally indicated for the treatment of Hodgkin lymphoma, was approved to treat adult patients with anaplastic large cell lymphoma and other CD30-expressing peripheral T-cell lymphomas on November 16, 2018.
  • Dupixent® (dupilumab) used for the treatment of atopic dermatitis, was expanded as an add-on maintenance treatment for patients with eosinophilic phenotype or with oral corticosteroid-dependent asthma on October 19, 2018.
  • Invokana® (canagliflozin) was expanded from its original indication for type 2 diabetes to include the reduction in risk for major adverse cardiovascular events on October 30, 2018.
  • Venclexta™ (venetoclax) originally indicated for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma was expanded for the treatment of acute myeloid leukemia.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for prostate cancer, rosacea, and two treatments for the rare and severe form of epilepsy, Lennox-Gastaut Syndrome. 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.