Teplizumab Among Clarivate's Drugs to Watch List for 2023

Teplizumab is the first immunotherapy to launch for type 1 diabetes (T1D), and its potential ability to preserve beta cell function and delay the need for insulin treatment makes it a “landmark drug,” according to Clarivate’s “Drugs to Watch” 2023 list.

“This year’s Drugs to Watch list from Clarivate is made up almost entirely of personalized medicines, treatments targeted to a particular biomarker, ensuring greater efficacy and less precious time lost searching for a drug or biologic that will arrest or reverse the progress of disease,” the company said. “These 15 therapeutics are likely to achieve blockbuster status by 2027, per Clarivate analysis, or are novel drugs that, if green lighted, could be clinical and/or commercial game changers for the benefit of millions of patients worldwide.”

Clarivate said it expected the drug to post $390 million in expected sales in 2027, a year after patents on the drug are estimated to expire. Additionally, "data from Cortellis indicate a 90% probability of success for teplizumab in Europe," the company said.

The 14 other drugs on the list are designed to treat several disease states, including plaque psoriasis, breast cancer, Alzheimer disease, and multiple blood– and kidney-related conditions, among others.

The full list includes:

• bimekizumab
• capivasertib
• daprodustat
• deucravacitinib
• donanemab
• foscarbidopa/foslevodopa
• lecanemab
• lenacapavir
• mirikizumab
• pegcetacoplan
• ritlecitinib
• sparsentan
• teclistamab
• teplizumab
• valoctocogene roxaparvovec

Teplizumab (Tzield) is an Fc receptor-nonbinding anti-CD3 monoclonal antibody administered via intravenous infusion once daily for 14 consecutive days. The biologic is the first immunotherapy on the market to delay the onset of T1D and received FDA approval in November 2022.

According to the report, teplizumab is anticipated to become a new mainstay for managing glycemic control—a title long-held by insulin, the cornerstone of T1D treatment.

Insulin works to maintain glycemic control and avoid glucose-related complications in patients with T1D. However, these patients often still struggle to maintain recommended glycemic levels, largely due to high treatment costs and complicated disease management. According to the report, disease modifying drugs like teplizumab can fill this treatment gap by potentially prolonging disease progression and improving patients’ quality of life.

There are still barriers, though, especially in clinical practice. These hurdles include identifying which patients need access to the drug most, since large-scale screening for risk will be challenging given that early T1D testing is not routinely conducted.

“Another consideration is that not all individuals with the relevant antibodies progress to T1DM, which might indicate the need for an additional screening stage to determine eligibility,” the report said. “Physicians also view the daily infusion for 12-14 days as burdensome and expect it to be a barrier to uptake.”

The report also noted that few T1D immunotherapies have made it to late-stage clinical development, adding that experts are optimistic about immunotherapies that can prevent or slow beta cell deterioration, which could potentially shift the T1D treatment paradigm.

“We are still far from immunotherapy being SOC [standard of care], but teplizumab has shown some potential,” said one unnamed US physician quoted in the report prior to the drug’s FDA approval. “If approved, we will see more patients being screened for autoantibodies and picked up prior to their clinical need for insulin. The challenges are going to be the cost and access. It is not an easy infusion because it takes 12 days—there are lots of other factors that will have to play out in terms of how realistic the drug is on the overall market.”