5 new drugs coming down the pipeline in 2021
From prostate cancer to lymphoma, these drugs offer hope for consumers, but they come with hefty price tags.
Despite concerns about the effect of COVID-19 on the FDA’s work in approving new pharmaceutical treatments, 2020 did not see a major drop-off in approvals, according to a new report from OptumRx.
OptumRx, a pharmacy benefits manager owned by UnitedHealth Group, recently released its OptumRx Drug Pipeline Insights Report. In addition to reporting on the general pace of approval of new drugs, it highlighted five notable drugs being reviewed by the FDA and their possible impact on the market in 2021.
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In the report, OptumRx noted that the COVID-19 pandemic and its associated impact on the health care industry raised fears that the FDA would slow approvals of drugs unrelated to that disease. However, the report said that as the year progressed, the overall robust capabilities of the industry and regulators allowed drug development to remain at near-normal levels.
“As the year begins to close, it does not appear that the pandemic has slowed the FDA’s approval process,” the report said. It also credited some changes at the FDA for the continued production. This included a more streamlined hiring process, which has increased staff at the agency, made possible in part by the passage of the 21st Century Cures Act of 2016.
New drugs to watch for in 2021
The report highlights five new drugs that are expected to make an impact on the market in 2021. These are:
1. Roxadustat—a drug that treats anemia associated with chronic kidney disease (CKD). The report noted that anemia is common in patients with CKD, and can be associated with increased risk of hospitalization, cardiovascular complications, and death. In the U.S., approximately 4.8 million individuals are affected with anemia associated with CKD; about 500,000 of them receive dialysis.
The manufacturer has applied to have Roxadustat approved for both the dialysis and the much larger non-dialysis market. One advantage of the treatment is that it provides an oral delivery system, as opposed to an injectable drug. The report noted that the price of Roxadustat has not been established, but a different drug to treat CKD anemia costs approximately $1,500 for 30 days.
2. Relugolix—this drug is designed to treat prostate cancer, the second-most common cancer in men in the U.S. Like other drugs that treat prostate cancer, it seeks to reduce levels of testosterone, which occurs naturally in the body. Relugolix blocks testosterone production through a mechanism that differs from current treatments. Trials have suggested the drug may be more effective than some current drugs, with fewer side effects. The drug would enter a competitive market, with one current drug in the market costing approximately $20,000 annually.
3. Inclisiran—a drug for treatment of low cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH). Over 29 million people are affected with ASCVD and FH in the U.S., and of these patients, about 22 million are treated with statin drugs. For those who don’t respond adequately to statins, Inclisiran may offer an add-on to statin treatment. Drugs in this class cost approximately $5,850 per year.
4. Berotralstat—Berotralstat is intended to prevent hereditary angioedema (HAE) attacks, a serious condition that causes swelling in various parts of the body and can be fatal when it affects breathing. Before therapies became available, the mortality rate for airway obstruction from HAE was as high as 30% of cases. Approximately 7,500 people are diagnosed and treated for HAE in the U.S.
The report noted that there are already well-established therapies for HAE, but that Berotralstat, unlike the current top therapies, is an oral treatment as opposed to being injected. There remain questions about whether the oral treatment is as effective as the injected therapies. The cost is expected to be lower than current therapies, which are approximately $591,000 per year.
5. Lisocabtagene maraleucel—this drug, which treats diffuse large B-cell lymphoma that has relapsed or not responded to other treatment, has seen a delay in its release due to some manufacturing restrictions caused by the COVID-19 pandemic. According to the report, the drug is a chimeric antigen receptor (CAR T) cell therapy, a therapy that takes naturally occurring infection-fighting T-cells, re-engineers them, and puts them back in the body to attack cancer cells. Like similar drugs, lisocabtagene maraleucel treatment is a one-time infusion that comes with several issues, including lack of long-term remission and challenges in preparation for the treatment. It is thought that the introduction of the new drug could lead to lower overall costs for this market. Current costs range from $373,000 to $475,000 for the one-time infusion.
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