From the marvel of the first RSV vaccines to a pioneering gene therapy, the 2024 edition of the Drugs to Watch report, compiled by the data analytics company Clarivate (CLVT), offers a fascinating look at the cutting edge of medical innovation.

The report, which focuses on 13 recently launched or upcoming drugs with game-changing potential, excludes treatments launched before 2023 and considers drugs launched early last year or undergoing Phase 2 and Phase 3 trials in the pre-registrational stage. It sheds light on new technology platforms that are likely to achieve significant proof of concept in 2024, including CRISPR-Cas9 gene editing and artificial intelligence/machine learning tool applications in drug discovery, clinical development, and commercial launch, according to Henry Levy, who leads Clarivate’s Life Sciences & Healthcare segment.

Regeneron’s High-Dose Eylea Takes the Lead

Regeneron’s recently launched eye disease therapy, high-dose Eylea, has claimed the top spot on the list. The VEGF inhibitor, indicated at 8 mg for retinal diseases, including diabetic macular edema (DME), is projected to generate $1.77B in 2027 sales for Eylea HD in G7 countries from patients with wet age-related macular degeneration (AMD) alone.

Regeneron, along with its partner Bayer, expects to recognize around $123M in U.S. net product sales for the drug in Q4 2023.

Calliditas Therapeutics’ Budesonide and AstraZeneca/Daiichi Sankyo’s Datopotamab Deruxtecan Take Second and Third Place

Calliditas Therapeutics’ delayed-release corticosteroid formulation, Budesonide, fully approved last year for adults with immunoglobulin A nephropathy, ranks second on the list. A cancer therapy from AstraZeneca and Daiichi Sankyo, Datopotamab deruxtecan, follows closely in third place, with promising potential for breast cancer and non-small cell lung cancer.

Daiichi Sankyo’s announcement about filing for U.S. approval led to a surge in the company’s Japan-listed shares this week, fueling anticipation for the treatment’s future impact.

Roche and Sobi’s Hemophilia Therapy, Verona Pharma’s COPD Therapy, and Pfizer/GSK’s RSV Vaccines Secure Their Spots

Roche and Sobi’s Factor VIII replacement therapy, efanesoctocog alfa for hemophilia A, claims the fourth rank on the list, offering hope for patients without access to novel treatments such as gene therapies.

Verona Pharma’s investigational therapy for chronic obstructive pulmonary disease (COPD), ensifentrine, is also among the drugs to watch, currently under FDA review, with a target action date of June 26, 2024.

The first FDA-cleared vaccines for respiratory syncytial virus (RSV), Abrysvo and Arexvy, developed by Pfizer and GSK/Agenus, also capture attention as potential game-changers in the fight against RSV.

Gene Therapies for Blood Disorders, Johnson & Johnson’s Prostate Cancer Therapy, and More

The list also includes one-time gene therapies, Casgevy and Lyfgenia from Crispr Therapeutics/Vertex Pharma and Bluebird Bio, targeting inherited blood disorders, sickle cell disease (SCD), and beta-thalassemia, representing a significant milestone in the treatment landscape for these conditions.

Johnson & Johnson’s investigational prostate cancer therapy, Akeega, estimated to achieve $2.7B in sales in 2029, and its bispecific antibody, Talvey, cleared in the U.S., also hold promise as breakthrough treatments.

Eli Lilly and Astellas Pharma claim the final spots on the list with their monoclonal antibodies, Omvoh and zolbetuximab, showcasing ongoing efforts to address challenging conditions such as ulcerative colitis and gastric or gastroesophageal junction cancer.

A Look Back and a Glimpse Forward

Looking back at the 2023 list, Clarivate highlighted 14 treatments as drugs to watch, with twelve of those granted regulatory approval. The challenges faced by some of these treatments underscore the complexities and uncertainties inherent in drug launches, as exemplified by Donanemab, Eli Lilly’s Alzheimer’s therapy, and Roctavian, BioMarin’s gene therapy for hemophilia A.

As the world of medical innovation continues to evolve, the Drugs to Watch report serves as a compass, guiding investors, healthcare professionals, and patients toward the bright horizons of breakthrough treatments and scientific advancements.