The FDA approved 50 novel drugs in 2021, down from 53 in 2020, including the first KRAS inhibitor (Sotorasib ) for cancer and the first anti-amyloid antibody (Aducanumab ) for Alzheimer's disease.
So, in 2022, how many drugs will be approved? Which drugs have blockbuster potential? Recently, Evaluate released a report with predictions for the industry's 2022 development. The report states that there are 10 innovative therapies that are likely to be approved in 2022 and are expected to be blockbusters in the future. Among them, Tezspire (tezepelumab-ekko) has already been approved for marketing early at the tail end of 2021. In this article, let's take a look at the remaining nine potential heavyweight therapies together.
Potential Blockbuster Drugs to be Approved in 2022, Image source: Reference 
Blockbuster Drugs To Be Approved in 2022
In 2021, the launch of the Alzheimer's disease therapy Aduhelm (aducanumab) was one of the biggest concerns in the industry and the beginning of a new wave of Alzheimer's disease R&D. Donanemab, developed by Lilly, a monoclonal antibody targeting beta-amyloid, met its primary endpoint in a Phase 2 clinical trial, slowing clinical progression by 32% in patients with early-stage Alzheimer's disease. The therapy received breakthrough therapy designation from the U.S. FDA last June. Lilly has also initiated a rolling submission for donanemab, seeking accelerated approval from the U.S. FDA for the treatment of Alzheimer's disease.
Tirzepatide is a GLP-1 and GIP receptor agonist that holds promise for the treatment of diabetes. In last October's issue of The Lancet, Lilly published detailed Phase 3 clinical results of this innovative therapy.In adult patients with type 2 diabetes with increased cardiovascular risk, all three doses of tirzepatide demonstrated better efficacy compared to glargine insulin, with greater reductions in patients' glycated hemoglobin (A1C) levels (2.58% vs. 1.44% at the highest dose) and body weight (-11.7 kg vs. +1.9 kg at the highest dose), and demonstrated 2-year sustained efficacy.
Lilly has submitted a listing application to the FDA in October 2021 and plans to use a priority review voucher. The therapy is expected to be approved in mid-2022.
Gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Alzheimer's disease (AD). Currently gantenerumab is undergoing testing in a Phase 3 clinical trial and is expected to have clinical data in the second half of 2022. Evaluate reports that if Roche takes the accelerated approval pathway, it is expected to make this therapy available in 2022.
Deucravacitinib (Bristol Myers Squibb)
In November 2021, Bristol-Myers Squibb announced that the U.S. FDA has accepted a New Drug Application (NDA) for deucravacitinib, a potential "first-in-class" oral selective TYK2 inhibitor, for the treatment of adults with moderate/severe plaque psoriasis. The press release states that deucravacitinib is expected to be the first approved TYK2 inhibitor. In phase 3 clinical trials, this innovative therapy demonstrated significant and clinically meaningful improvements in skin symptom clearance, symptom burden and quality of life indicators as assessed by PASI 75 and sPGA 0/1 compared to placebo and active controls. Moreover, it was well tolerated with a low rate of discontinuation due to adverse events. According to publicly available information, the PDUFA date for deucravacitinib is September 10, 2022. It is also expected to be approved in the EU in October this year.
Bardoxolone is an activator of nuclear factor erythroid-related factor 2 (Nrf2). Nrf2 is a transcription factor that induces multiple molecular pathways that attenuate the inflammatory response and tissue fibrosis process by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
Bardoxolone has met the primary endpoint and critical secondary endpoint in a Phase 3 study for the treatment of patients with Alport Syndrome (AS)-associated chronic kidney disease, significantly improving patients' estimated glomerular filtration rate (eGFR). It is currently under review by the U.S. FDA. In accordance with the PDUFA date, the FDA is expected to provide a response on or before February 25, 2022.
Vutrisiran is an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis, including hATTR and wild-type ATTR (wtATTR) amyloidosis. It blocks the production of wild-type and variant transthyretin (TTR) proteins by targeting and silencing specific mRNAs. In the phase 3 trial, this therapy was obtained for the primary endpoint and all secondary endpoints. That is, statistically significant improvements in important domains of patient health and function were observed with vutrisiran compared to placebo. vutrisiran is currently under review by the U.S. FDA with a PDUFA date of April 14, 2022. It is also expected to be approved in the EU in the fourth quarter of this year.
Mavacamten (Bristol-Myers Squibb)
Mavacamten is a potential "first-in-class" cardiovascular drug acquired by Bristol-Myers Squibb through its acquisition of MyoKardia, which inhibits cardiomyosin for the treatment of obstructive hypertrophic cardiomyopathy (oHCM). Bristol-Myers Squibb has filed a marketing application with the U.S. FDA for this therapy, with an updated PDUFA date of April 28, 2022.
Cilta-cel ( Johnson & Johnson/ Legendary Biologics )
Carvykti (cilta-cel), jointly developed by Janssen and Legendary Biologics, is a CAR-T therapy targeting B-cell maturation antigen (BCMA). Data presented last year at the 63rd Annual Meeting of the American Society of Hematology (ASH) showed that cilta-cel demonstrated durable anticancer activity in the treatment of patients with relapsed/refractory multiple myeloma who had been treated with multiple prior therapies. At a median follow-up time of 22 months, 83% of patients achieved strict complete remission. Cilta-cel has been granted priority review by the U.S. FDA with a PDUFA date of February 28, 2022. The EU is likewise expected to approve this therapy in the first quarter of this year.
Adagrasib (Mirati Therapeutics)
Adagrasib, a highly specific and potent oral KRAS G12C inhibitor, has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of patients with treated non-small cell lung cancer harboring KRAS G12C mutations.
In phase 2 clinical trials, this therapy achieved an objective remission rate (ORR) of 43%, and a disease control rate (DCR) of 80%. Notably, 98.3% of patients treated with adagrasib had already received immunotherapy and chemotherapy, so it is a new hope for these patient groups. Earlier this year, Mirati plans to release more detailed data, and Evaluate reports that the company may use the accelerated approval pathway.
 Evaluate Vantage 2022 Preview, Retrieved January 2, 2022, from https://www.evaluate.com/thought-leadership/vantage/evaluate-vantage-2022-preview-report