In the Pipeline: Non-Specialty Drugs to Watch in 2021

COVID-19 vaccines are just one type of medication seeing significant development. Learn about the most important non-specialty drugs coming this year.

If you missed last week’s article about upcoming specialty drugs, be sure to check it out here . To learn more about what it takes to bring a new drug to market, check out our article here.

Our pharmacists continually monitor the drug development pipeline to help clients stay ahead of the curve on new and upcoming medications. Here are the most important non-specialty drugs for 2021:

Covid-19

COVID-19 dominated the headlines last year as manufacturers and governments worked to produce a working vaccine amid the global pandemic. The FDA granted emergency use authorization (EUA) in late 2020 for vaccines from Pfizer/BioNTech and Moderna, allowing their distribution across the country. We anticipate EUAs for other COVID-19 vaccines in 2021, including those developed by AstraZeneca and Johnson & Johnson. This will not only increase much-needed availability, but can also reduce storage and administration burdens compared to current vaccines, which require storage at extremely low temperatures and two separate injections.

Although these vaccines have shown promising results, questions still exist about the length of immunity they provide and their effectiveness in children. We expect data on these questions to continue to be released in 2021.

Heart failure occurs when the heart is unable to pump enough blood and oxygen to support the body’s organs. It affects 6.2 million adults in the United States and was responsible for almost 380,000 deaths in 2018.¹

• Verquvo® (vericiguat) was approved on January 20, 2021 as the first oral guanylate cyclase stimulator for treating heart failure. It can reduce the risk of cardiovascular hospitalization and death from heart failure with reduced ejection fraction, a more serious form of the condition. Vericiguat’s indication may expand to include less serious types of heart failure. Vericiguat was used with other common heart failure medications in trials, including Entresto® (sacubitril/valsartan).
• In December 2020, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted in favor of expanding indications for two drugs currently used to treat heart failure, Entresto® (sacubitril/valsartan) and Spironolactone. Although this is a nonbinding decision, the FDA typically follows the committee’s recommendations.
• The FDA has started approving SGLT2 inhibitors, originally approved for the treatment of type II diabetes, for additional indications including heart failure with reduced ejection fraction. Farxiga® (dapagliflozin) was approved by the FDA in May 2020 and Jardiance® (empagliflozin) is expected to receive an FDA decision near the end of 2021.

HIV

HIV attacks the body’s immune system and can lead to AIDS. Over the last 10 years, HIV treatments have become more effective with fewer adverse effects. Treatments can now be tailored to individuals for greater effectiveness and adherence.

• Cabenuva (cabotegravir/rilpivirine) is a complete antiretroviral injection that only needs to be administered by a healthcare provider once a month. Approved by the FDA on January 21, 2021, it may significantly improve adherence, which is vital for treating HIV.
• The long-acting injectable formulation of cabotegravir was designated as a breakthrough therapy in late 2020 for use in HIV pre-exposure prophylaxis. In clinical trials, this every-eight-week injection was shown to be superior at preventing HIV compared to Truvada® (emtricitabine/tenofovir disoproxil).
• The approval of generic emtricitabine/tenofovir disoproxil, used to prevent and treat HIV, was another significant change in 2020. As more manufacturers release generics in 2021, the reduction in price should make them even more accessible.

Influenza

Influenza (flu) is a respiratory disease that can cause mild to severe illness. Precautions related to COVID-19, including mask wearing and social distancing, have led to significantly fewer cases in the 2020-2021 flu season.²

• Xofluza® (baloxavir) is a flu treatment that was approved in November 2020 for a new indication to prevent influenza after exposure to someone with the flu. Although this expansion’s impact is likely reduced by this year’s milder flu season, baloxavir may see increased use in future years.

Staying ahead of significant new drugs can help reduce their impact on your organization’s drug spend and improve your members’ heath.

1. Heart Failure. CDC.gov. https://www.cdc.gov/heart-disease/about/heart-failure.html. Updated May 15, 2024. Accessed December 17, 2024.
2. Weekly U.S. Influenza Surveillance Report. CDC.gov. https://www.cdc.gov/flu/weekly/index.htm. Updated January 8, 2021. Accessed January 14, 2021.