Alkermes Gets FDA approval for Aristada Initio (aripiprazole lauroxil) as Part of Schizophrenia Treatment Combination
Alkermes has announced that the U.S. FDA approved ARISTADA INITIO (aripiprazole lauroxil) for the initiation of ARISTADA (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of Schizophrenia in adults. For the first time, ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, provides physicians with an alternative regimen to initiate patients onto any dose of ARISTADA on day one. ARISTADA INITIO is expected to be available in mid-July 2018.
Eisai and Biogen Announce Positive Topline Results of Final Analysis for BAN2401 in Early Alzheimer’s Disease Patients at 18 months
Eisai and Biogen have announced the positive topline results of the phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography). This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis. The new data provide compelling evidence to further support amyloid hypothesis as a therapeutic target for Alzheimer’s disease.
Anavex Receives Approval to Initiate Phase IIb/III Clinical Trial of ANAVEX 2-73 for Early Alzheimer’s Disease Treatment
Anavex has received approval of the Australian Human Research Ethics Committee to initiate its phase IIb/III double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX 2-73 for the treatment of early Alzheimer’s disease.
The phase IIb/III study is scheduled to initiate enrollment of approximately 450 patients, randomized 1:1:1 to two different ANAVEX 2-73 doses or placebo within the next month. As part of the planned international study, North American sites will be added. ANAVEX 2-73 is being studied as potential first precision medicine biomarker-guided, targeted therapeutic in Alzheimer’s disease.
Biohaven expands Rimegepant (small molecule calcitonin gene-related peptide (CGRP) receptor antagonist) Development Program to Include Data of Two Pivotal Migraine Phase III Clinical Trials
Biohaven has presented expanded data from two randomized, pivotal phase III clinical trials of rimegepant, Biohaven’s small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, on June 30, 2018 at the American Headache Society (AHS) Annual Scientific Meeting 2018. These data support rimegepant’s potential to provide patients with pain freedom and freedom from the most bothersome migraine-associated symptom in the acute treatment of migraine using a single dose. The phase III trial to evaluate rimegepant as a preventive therapy for migraine is expected to begin by the fourth quarter of 2018.