News on Approval of the First Interchangeable Biosimilar Insulin and More

From development of a medication for treatment-resistant HIV with a novel mechanism of action to approval of Pfizer's COVID-19 vaccine, learn about the most impactful changes at each stage of the drug pipeline in this edition of Perspective on the Rx Pipeline.

Perspective on the Rx Pipeline

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:

  • GS-6207, a medication for treatment-resistant HIV-1 patients with a novel mechanism of action that interrupts several stages of the viral lifecycle, potentially keeping the virus from becoming infectious and invading uninfected cells.  
  • TEZSPIRE™, a biologic for the treatment of asthma with a new mechanism of action that may impact a broad population of severe asthma patients. 
  • MK-7264, if granted FDA approval, would be the first treatment specifically for refractory chronic cough, which is currently often treated with off-label products.      

Drug Approvals

Seven drugs recently approved by the FDA include:

  • Bylvay™ (odevixibat), the first FDA-approved treatment for pruritus (itching) due to progressive familial intrahepatic cholestasis.  
  • Comirnaty® (COVID-19 vaccine mRNA), previously granted emergency use authorization status, this first-of-its-kind mRNA vaccination for COVID-19 has been granted full FDA approval for those 16 years of age and older.
  • Kerendia® (finerenone), approved to reduce the risk of complications in patients with chronic kidney disease and type 2 diabetes.
  • Korsuva™ (difelikefalin) has been approved as a treatment of pruritus for those with chronic kidney disease undergoing hemodialysis.
  • Rezurock™ (belumosudil), a new pharmacological option for refractory graft-vs-host disease, a common complication of allogenic hematopoietic cell transplants.
  • Saphnelo™ (anifrolumab), the first drug for the treatment of systemic lupus erythematosus in over 10 years, offering a new mechanism of action.
  • Semglee® (insulin glargine-yfgn) is the first FDA-approved biosimilar insulin that is interchangeable, or can be substituted for Lantus®.

New Indications

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

  • Brukinsa® (zanubrutinib), approved to treat Waldenström's macroglobulinemia, it received the additional indication to treat patients with relapsed or refractory marginal zone lymphoma.
  • Invega Hafyera™ (paliperidone) is a twice-yearly injectable antipsychotic for schizophrenia.
  • Jardiance® (empagliflozin) was expanded to reduce the risk of cardiovascular disease death plus hospitalizations in patients with heart failure.
  • Pradaxa® and Pradaxa® pellets (dabigatran etexilate) was approved for pediatric indications related to venous thromboembolic events (VTE) and for reducing the risk of VTE recurrence, making it the first oral blood thinning medication approved for children.
  • Xarelto® (rivaroxaban), approved for the indication to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease.
  • Xywav® (calcium oxybate; magnesium oxybate; posassium oxybate; sodium oxybate) received the additional indication to treat idiopathic hypersomnia.

Generic Approvals

There are several new generic product offerings to the marketplace, including drugs for the treatment of hypertension, arthritis and multiple sclerosis. A review of generic launches, including biosimilars, is provided in the full report.

Download the full report for more information, including important safety updates and drug shortages and discontinuations.

Topics: Perspective on the Rx Pipeline