Which late-stage drug candidates or recently approved drugs of the large bio/pharmaceutical companies are poised for high peak-sales potential or potentially blockbuster status? DCAT Value Chain Insights takes an inside look of the key pipeline contenders.

Potential blockbusters on tap
Several products, launched or expected to launch in 2022, are projected for blockbuster status, defined as products with sales of $1 billion or more. Earlier this year (January 2022), Clarivate Analytics released a report, Drugs To Watch 2022, which identified potential blockbuster products by 2026. For purposes of the analysis, the candidates were in Phase II or Phase III trials, at pre-registration or registration stage, or already launched in 2021, including drugs launched for a new indication that could be particularly impactful on the industry; drugs launched prior to 2021 were excluded. Key products from the large bio/pharma companies from this analysis included: faricimab by Roche and Chugai Pharmaceutical; tezepelumab by Amgen and AstraZeneca; tirzepatide by Eli Lilly and Company; lecanemab by Eisai and Biogen and donanemab by Eli Lilly and Company.

Roche’s/Chugai Pharmaceutical’s Vabysmo (faricimab) was approved by the FDA earlier this year (January 2022) to treat two eye disorders: neovascular (wet) age-related macular degeneration and diabetic macular edema.

Amgen’s/AstraZeneca’s, Tezspire (tezepelumab-ekko) was approved in the US in December 2021 as an add-on maintenance treatment for severe asthma. Tezspire is also being evaluated for other potential indications, including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis.

Eli Lilly and Company’s Mounjaro (tirzepatide) was approved in the US in May (May 2022) for improving blood sugar control in adults with Type 2 diabetes as an addition to diet and exercise.

Eisai’s/Biogen’s lecanemab and Lilly’s donanemab are two drugs for treating Alzheimer’s disease, which had been projected for possible launch in 2022 and subsequent blockbuster status although the path forward is less certain. Both drugs are anti-amyloid drugs, and earlier this year (2022), another anti-amyloid drugs for treating Alzheimer’s disease, Eisai’s/Biogen’s Aduhelm (aducanumab), had a setback when the US Centers for Medicaid and Medicare Services (CMS) limited coverage of Aduhelm under Medicare, the US federal health insurance program for individuals over the age of 65, for Aduhelm and other future monoclonal antibody-based amyloid drugs for treating Alzheimer’s disease.

Aduhelm was approved under the FDA’s accelerated approval pathway in June 2021. The accelerated approval pathway allows for earlier approval of drugs that treat serious conditions and that fill an unmet medical need but requires post-approval confirmatory trials. The CMS issued a national policy for coverage of Aduhelm and any future monoclonal antibodies directed against amyloid for treating Alzheimer’s disease that are approved under FDA’s accelerated approval pathway only to patients taking part in approved clinical trials, which includes post-approval confirmatory trials. If the post-approval trials confirm clinical benefit, then the drug may receive traditional approval. The narrow Medicare reimbursement policy for Aduhelm and other factors contributed to weak sales; the drug posted second-half 2022 sales of only $2.9 million. During the fourth quarter of 2021, due to reduced future expected revenue associated with Aduhelm, which had been touted as a potential blockbuster, recorded a valuation allowance of approximately $390 million.

Despite the setback with Aduhelm, Biogen and Eisai are continuing development of another monoclonal antibody-based amyloid drug, lecanemab, although projected FDA review of the drug has been pushed to early 2023. In July (July 2022), the FDA accepted the biologics license application under the accelerated approval pathway for Biogen’s/Eisai’s lecanemab with an FDA review action date of January 6, 2023. Lilly, too, is progressing its monoclonal antibody-based amyloid drug for treating Alzheimer’s  drug, donanemab. Last month (August 2022), Lilly received a priority review designation for donanemab under FDA’s accelerated approval pathway. Phase III trials are ongoing.