AbbVie is set to acquire Cerevel Therapeutics for $8.7 billion, Novartis' Fabhalta (iptacopan) has gained FDA approval for PNH, and Pfizer has faced setbacks with its obesity drug danuglipron. These developments highlight a dynamic week in the pharmaceutical industry, marked by strategic acquisitions, regulatory milestones, and clinical trial outcomes.
AbbVie's Neuroscience Expansion
AbbVie's planned acquisition of Cerevel Therapeutics for $8.7 billion aims to significantly strengthen its neuroscience pipeline. Cerevel's portfolio includes promising candidates like emraclidine (Phase II for schizophrenia), tavapadon (Phase II for Parkinson's disease), and darigabat (Phase II for epilepsy and panic disorder). Data readouts for these candidates are expected in 2024. This acquisition underscores AbbVie's commitment to addressing psychiatric and neurological disorders with novel therapeutic approaches.
Novartis' Fabhalta Approved for PNH
Novartis has secured FDA approval for Fabhalta (iptacopan) as the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare and chronic blood disorder. The approval was based on the APPLY-PNH study in adults with PNH and anemia despite prior anti-C5 treatment and supported by the APPOINT-PNH study in complement inhibitor-naïve patients. Fabhalta's approval offers a new treatment option for PNH patients, potentially improving their quality of life. Novartis anticipates launching Fabhalta in December and is also investigating its potential in other complement-mediated diseases, including IgA nephropathy and C3 glomerulopathy.
Pfizer's Obesity Drug Setback
Pfizer has decided not to proceed with Phase III studies for its twice-daily oral GLP-1R agonist, danuglipron, due to high rates of gastrointestinal side effects observed in a Phase IIb study involving adults with obesity. While the study demonstrated placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks, discontinuation rates exceeded 50% across all doses, significantly higher than the placebo group (approximately 40%). This setback represents a significant challenge to Pfizer's ambitions in the rapidly growing market for GLP-1 drugs targeting obesity. The company is continuing pharmacokinetic studies of a once-daily formulation of danuglipron to determine future development plans.
Lilly's Jaypirca Receives Second FDA Nod
Eli Lilly's BTK inhibitor Jaypirca (pirtobrutinib) has received accelerated FDA approval for its second indication: chronic lymphocytic leukemia (CLL). This approval is specifically for adult patients with CLL or small lymphocytic lymphoma who have previously undergone at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. The decision was based on data from the Phase I/II BRUIN study, which demonstrated an overall response rate of 72% in this patient population.
Biogen and Eisai's Leqembi Gains Full FDA Approval
Biogen and Eisai announced that the FDA has approved the supplemental biologics license application (sBLA), supporting the traditional approval of their Alzheimer’s disease (AD) drug Leqembi. The traditional approval is based on data from Eisai’s late-stage global Clarity AD clinical study, wherein Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of Leqembi. Leqembi is the first and only approved anti-amyloid antibody treatment shown to reduce the rate of disease progression and slow cognitive impairment in the early and mild dementia stages of AD indication.
Roche to Acquire Carmot Therapeutics
Roche has entered into an agreement to acquire Carmot Therapeutics, a biotech company focused on developing subcutaneous and oral incretins for obesity treatment. Carmot's lead candidate, CT-388, a dual GLP-1/GIP receptor agonist, has shown promising weight loss results in Phase Ib studies. This acquisition reflects Roche's strategic interest in expanding its portfolio in the obesity and metabolic disease space.
