Amgen’s Vectibix fails to meet main goal in trial
THOUSAND OAKS, Calif. An investigational biotech drug didn’t significantly improve patients’ survival, according to results of a late-stage clinical trial announced by Amgen Wednesday.
The biotech company said data from a phase 3 trial of Vectibix (panitumumab) as a first-line treatment for a form of head and neck cancer added to platinum-based chemotherapy didn’t achieve the main goal of producing greater rates of survival than chemotherapy alone. The drug did produce a greater rate of survival without progression of the disease, but the results were not tested for statistical significance.
“The outcome of this study is disappointing,” Amgen EVP research and development Roger Perlmutter said. “However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies.”
Curemark gets nod to start late-stage trial for ADHD drug
RYE, N.Y. The Food and Drug Administration has approved a late-stage clinical trial of a drug for attention deficit hyperactivity disorder.
Curemark said the FDA cleared its application to run a phase 3 trial of CM-4612 in patients with ADHD. The company is currently conducting a phase 3 trial of CM-AT, a treatment for autism in children.
“We are very excited to have received [clearance] from the FDA so that we can move forward with clinical trials to study CM-4612,” Curemark CEO Joan Fallon said. “Curemark hopes to have the first physiologically based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments.”
FDA approves additional dosage for NovoSeven RT
PRINCETON, N.J. The Food and Drug Administration has approved a new dose of a treatment for hemophilia from Novo Nordisk, the Danish drug maker said.
The FDA approved Novo Nordisk’s NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable) in 8-mg vials. The treatment, which comes in the form of a powder mixed for injection, was already available in 1, 2 and 5 mg vials. The FDA also approved an extension of shelf life for all vial sizes from 24 months to 36 months at or below 77 degrees.
NovoSeven RT is formulated for patients with hemophilia A or B with inhibitors. The new dosage will shorten the time it takes to prepare the injection, known as reconstitution, compared with current dosages.