Specialty Meds Lining Up for 2021

When it comes to specialty pharmacy medications, 2021 is looking to be an exciting year of new medications cued up for FDA review and (fingers crossed) approval. The pipeline is full, which means that patients will have more choices than ever for treating many complex and challenging conditions.

Despite an unusual year in 2020, the pharmaceutical industry amazingly continued to develop drugs at near-normal levels. Last year, 27 of the 49 new drugs and biologics approved by the FDA met the criteria of ‘specialty medications.’ A similar trend is expected for 2021. This means that the current year could see a flurry of FDA approvals for new specialty medications.

Keep Your Eye Out For…

Cancer: Numerous new medications are expected in this treatment area, including:

  • Oraxol from Athenex Pharmaceuticals for metastatic breast cancer,
  • Relugolix oral from Myovant/Sumitomo Dainippon Pharma for androgen sensitive, advanced prostate cancer
    Umbralisib from TG Therapeutics from marginal zone lymphoma, and
  • Tepotinib from EMD Serono/Merck for non-small cell lung cancer.

Multiple Sclerosis: Actelion/Johnson & Johnson is expected to get approval for ponesimod oral, which offers an additional oral option for patients with relapsing forms of MS.

Nonalcoholic steatohepatitis: Allergan and Takeda is seeking approval for cenicriviroc mesylate which is an oral CCR2/5 dual antagonist.

Psoriasis: UCB is submitting bimekizumab for approval to treat psoriasis and psoriatic arthritis.

Psoriasis (and more): Eli Lilly has an SC IV IL-23 antibody called mirikizumab that treats psoriasis, ulcerative colitis, and Crohn’s disease.