With a busy 2021 under its belt, the pharmaceutical industry is gearing up for 2022.
The U.S. Food and Drug Administration is expected to approve several new highly-anticipated drugs, which means several potential blockbusters may be on their way to the U.S. market. The U.S. is still pharma’s largest and most profitable market and the agency is looking to usher in new medical breakthroughs. A report by Evaluate Vantage revealed several companies and drugs to keep an eye on this year.
Overall, Eli Lilly & Company and Bristol Myers Squibb have multiple potential blockbusters in their respective pipelines for 2022, and two treatments for Alzheimer’s disease — which have been a hot topic following the FDA’s approval of Biogen’s Aduhelm — appeared on the list.
With many things on the horizon for the pharma world in 2022, here are some of the rising stars to be on the lookout for this year.
New and in theaters
Tezepelumab, estimated sales of $2 billion by 2026 (Amgen, AstraZeneca)
On December 17, the FDA approved tezepelumab, which will be sold under the name Tezspire, as an add-on treatment for patients with severe asthma. The treatment is a first-in-class biologic for severe asthma that reduces symptoms of asthma. The drug works by preventing airway inflammation that is usually associated with severe asthma.
Tezspire was granted Orphan Drug Designation by the FDA in October 2021 for treatment of eosinophilic esophagitis (EoE), a chronic inflammation of the esophagus.
The mAb, which will be jointly commercialized by AstraZeneca and Amgen, was born from a collaboration that started back in 2012. Both companies will continue to share costs and profits equally after AstraZeneca pays an inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing.
Coming soon to a pharmacy near you
Tirzepatide, estimated sales of $4.9 billion by 2026 (Eli Lilly & Company)
Eli Lilly is keeping its eggs in a few baskets, with another possible player on the list. Tirzepatide, intended as a treatment for patients with type 2 diabetes or obesity, has major blockbuster potential, if approved. Clinical trials showed the drug has the potential to improve blood sugar levels and weight loss in patients.
If approved, Eli Lilly’s drug will compete with Novo Nordisk’s semaglutide and Sanofi’s Lantus. All three therapies use insulin glargine as the active ingredient. Lilly plans to use a priority review voucher and expects tirzepatide to be approved around mid-year in the U.S., E.U. and Japan.
Gantenerumab, estimated sales of $2.5 billion by 2026 (Roche Holding)
Roche hopes that gantenerumab will be the second Alzheimer’s drug to make it to market. The drug, an amyloid-beta blocker, has an expected launch date of 2022 if Roche files for U.S. accelerated approval, according to Evaluate. The drug was granted breakthrough therapy designation by the FDA on October 12, 2021.
Deucravacitinib estimated sales of $2.4 billion by 2026 (Bristol Myers Squibb)
From Bristol Myers Squibb, this TYK2 inhibitor has intended uses in treating psoriasis and other autoimmune conditions. TYK2 inhibitors act by blocking the action of the TYK2 gene, which is responsible for immune and inflammatory signaling in the body, to reduce inflammation. An approval decision is expected in Sept. 2022. The E.U. is expected to make the call on the drug in late 2022.
Stalled in production
Donanemab, estimated sales of $6 billion by 2026 (Eli Lilly & Company)
Eli Lilly's donanemab carried heavyweight potential, before hitting setbacks. The Alzheimer’s drug, an investigational antibody that targets a modified form of beta amyloid called N3pG, received breakthrough therapy designation from the FDA in June 2021 and was on the path to accelerated approval.
However, in early Feb. of this year, the company decided to push back its timeline for approval, deferring its application for the drug’s accelerated approval. The delay came as a result of the recent Medicaid decision, inspired by Biogen's Aduhelm, to restrict coverage for Alzheimer’s drugs to patients taking part in approved clinical trials.
Bardoxolone, estimated sales of $2.2 billion by 2026 (Reata)
Reata Pharmaceuticals, a Texas-based biopharma that specializes in developing novel therapeutics for patients, was expected to receive FDA approval for their kidney drug, bardoxolone, on February 25. The drug is an nrf2 activator that was intended to be used in the treatment of rare and chronic kidney diseases. It works by regulating antioxidant proteins and prevents kidney damage from progressing by protecting cells from oxidative damage.
The prognosis didn't look good following the FDA advisory committee's unanimous 13 to 0 determination that the med was not effective in late Dec. 2021. Not surprisingly, received a complete response letter from the FDA, despite the agency granting it Orphan Drug designation back in 2017. According to Reata, the agency did not find evidence to show that the drug was effective in slowing the loss of kidney function in patients with Alport syndrome, a rare genetic form of chronic kidney disease, or reducing the risk of progression to kidney failure. The FDA has requested additional data to support the efficacy and safety of the drug.