ABBVIE

2024 saw significant clinical successes and failures in biopharma, with Vertex, BMS, and Alnylam achieving notable wins, while AbbVie, Sage Therapeutics, Pfizer, and Gilead faced setbacks in neurological and other indications. Despite high failure rates in drug trials, particularly in CNS diseases, some companies advanced new treatments, while others faced challenges in their pipelines.

Precision medicine in mental health, driven by genetic solutions, promises personalized treatments, addressing efficacy and side effects. Adaptive trial designs accelerate drug development, while ethical concerns and infrastructure changes are challenges. Financial investments and community advocacy shift focus to integrative care models.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

Clene receives FDA guidance on accelerated approval for CNM-Au8 in ALS, planning biomarker analysis. uniQure aligns with FDA on accelerated approval pathway for AMT-130 in Huntington disease. AbbVie's tavapadon meets primary and secondary endpoints in early Parkinson disease phase 3 trial.

FDA approves CRENESSITY, first new treatment in 70 years for classic congenital adrenal hyperplasia (CAH), supported by largest clinical trial program in CAH. CRENESSITY, an oral corticotropin-releasing factor type 1 receptor antagonist, reduces excess ACTH and adrenal androgen production, enabling glucocorticoid dose reduction. Expected commercial availability in one week.

Biosimilars for Humira saw low uptake in their first year, but led to lower net spending due to AbbVie’s rebates. Biosimilar prescriptions rose from 0.03% to 1.35% by Q4 2023, with net sales dropping 45% to $2.8 billion. Despite lower net prices, Humira remained cheaper than biosimilars. Concerns exist over biosimilar market sustainability and future biosimilar development.

AbbVie to acquire Nimble Therapeutics for $200M, gaining its oral peptide drugs for immune diseases and technology for peptide-based drug synthesis. Nimble's lead candidate inhibits IL-23, same target as AbbVie's Skyrizi, and is in preclinical testing. The acquisition aims to strengthen AbbVie's immunology pipeline.

The Breakthrough Therapies Market was valued at USD 150.6B in 2024, projected to reach USD 287.5B by 2029, growing at a CAGR of 13.80%. The report analyzes BTD's risks, benefits, fast-track drug development, therapy areas, leading companies, and market dynamics.

Parkinson's disease market to grow at 5.8% CAGR (2020-2034) due to advancements in diagnostics, increased awareness, and a rising number of cases. Emerging therapies like Supernus/Britannia's SPN-830, AbbVie's tavapadon, and Pharma Two B's P2B001 could significantly impact market dynamics. DelveInsight's report covers current treatment practices, emerging drugs, market share, and forecasted market size (2020-2034) for 7MM.

AbbVie completed acquisition of Aliada Therapeutics, bringing ALIA-1758, an Alzheimer's treatment in Phase 1 trials, into its pipeline. AbbVie plans to advance ALIA-1758 and leverage Aliada's CNS drug delivery platform for neuroscience development.