OptumRx, the pharmacy benefit manager unit of UnitedHealth Group, shared five investigational drugs to watch through the end of 2021 in its latest quarterly Drug Pipelines Insights Report.
Below is a summary of the five drugs.
1. Bimekizumab. The monoclonal antibody treatment is used to treat adults with moderate to severe plaque psoriasis. The FDA was set to approve the drug by Oct. 15, but delayed its decision because of COVID-19-related travel restrictions that have prevented the agency from conducting on-site facility inspections in Europe. The treatment has held up against competing drugs in clinical trials, but is slated to enter a crowded market of other well-established psoriasis drugs.
2. Plinabulin. This drug is designed to prevent neutropenia, a common side effect of chemotherapy. The FDA's decision on plinabulin was slated for Nov. 30, though the agency has not released any notice about the drug's approval.
3. AXS-05 (dextromethorphan and bupropion). AXS-05 is designed to treat adults with major depressive disorder and is a combination of dextromethorphan, an over-the-counter cough medicine, and bupropion, a widely prescribed antidepressant. The combination appeared to work faster than other commonly used antidepressant treatments in clinical trials. The FDA is still reviewing AXS-05's new drug application.
4. Efgartigimod. This drug is used to treat generalized myasthenia gravis, a rare autoimmune disease that causes weakness in the skeletal muscles. The drug would likely be used for severe cases, as immunotherapy is the current standard of care for the condition. The FDA is slated to make a decision on efgartigimod Dec. 17.
5. Ciltacabtagene autoleucel. This CAR T-cell therapy is designed to treat patients with relapsed and/or refractory multiple myeloma. While trial results have been positive, the drug will likely have a high one-time cost and similar risks as other CAR T-cell therapies, such as cytokine release syndrome and neurotoxicity. The FDA moved its approval deadline for the drug from Nov. 29 to Feb. 28.