At a Glance:

Recent Approvals

  • Epidiolex (cannabidiol) – Treats severe, early-onset, treatment-resistant epilepsy syndromes.
  • Retacrit (epoetin alfa-epbx) – Biosimilar to Epogen/Procrit (epoetin alfa) to treat anemia caused by chemotherapy, kidney disease anemia, and HIV medication (AZT).
  • Lucemyra (lofexidine hydrochloride) – Approved under the Priority Review process. Used to reduce the severity of opiate withdrawal symptoms in adults.
  • Tavalisse (fostamatinib disodium) – New 2nd line medication for chronic thrombocytopenia blood disorder (platelet disorder) where limited effective treatment options exist.
  • Aimovig (erenumab-aooe) – A new biologic indicated for the preventive treatment of migraine headaches in adults.
  • Plenvu – A low volume bowel prep indicated for cleansing of the colon prior to a colonoscopy.
  • Olumiant (baricitinib) – Treatment of moderate to severe RA with an inadequate response to one or more tissue necrosis factors (Enbrel®, Humira®, Simponi®, Cimzia®, Remicade®).

Anticipated FDA Approvals

  • Ibalizumab – Biweekly biologic injectable treatment for multidrug resistant HIV.
  • Translarna (ataluren) – First-in-class oral indicated to treat the underlying cause of Duchenne muscular dystrophy,Previous new treatments targeted the specific nerve dysfunction.
  • Inotersen – Under Priority Review. Prevention of hereditary TTR Amyloidosis. Currently no or limited effective treatment options.

Anticipated Biosimilars FDA Review

  • Biosimilar to Rituxan® (rituximab) – For treatment of cancer, rheumatoid arthritis, and polyangiitis.
  • Biosimilar to Herceptin® (trastuzumab) – For treatment of HER2 adjuvant breast cancer, metastatic breast cancer, and metastatic gastric cancer.