MedImmune responds to FDA inquiry regarding motavizumab.
AstraZeneca PLC, the London pharmaceutical that owns MedImmune, said the local subsidiary has filed its formal responses to the Food and Drug Administration's questions about motavizumab, an enhanced version of MedImmune's blockbuster drug Synagis." According to the Business Journal, the drug, which treats respiratory syncytial virus disease in infants, "has hit its share of delays to market."
Combination therapy with mirtazapine may be more effective than fluoxetine alone.
According to a study published online Dec. 15 in the American Journal of Psychiatry, "mirtazapine used in combination with fluoxetine, venlafaxine, or bupropion is more effective and as well tolerated in treating major depressive disorder (MDD) as fluoxetine alone." After treating "a total of 105 patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, criteria for MDD," researchers found that "patients treated with these combinations had mean differences of 4.5 to 4.8 points on the Hamilton Depression Rating Scale (HAM-D) by day 42, compared with those treated with monotherapy."
FDA says Aridol cannot be approved in present form.
Pharmaxis, Ltd. reported that it has received a so-called complete response letter from the US Food and Drug Administration saying the application for its lung-function test Aridol [mannitol dry powder for inhalation] couldn't be approved in the present form." The agency "cited deficiencies at three manufacturing and testing subcontractors, a labeling issue, and post-marketing requirements, Pharmaxis said in a statement." The company plans to "address the issues and seek approval as soon as possible," Pharmaxis CEO Alan Robertson said. Aridol, which is already "approved for sale in Australia, major European countries, and Korea," is "a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness."
Monoclonal antibody may be promising in Ewing's sarcoma.
A monoclonal antibody that targets an insulin-like growth-factor receptor (IGF-1R) was well tolerated and demonstrated antitumor activity in refractory Ewing's sarcoma," according to research appearing online in Lancet Oncology. In a study of "29 patients with advanced sarcomas treated with figitumumab," researchers assessed "tumor response...every six to eight weeks by CT, MRI, or both." The study showed that "two patients...had confirmed responses," and eight "had disease stabilization." Researchers found "no cardiac toxicity," and "no substantial change in cardiac valve function or left ventricular ejection fraction," which they said "was noteworthy...because IGF-1R is expressed on cardiac myocytes, and three-quarters of the patients had previously received potentially cardiotoxic anthracyclines."
Patients with MDD taking paroxetine may undergo greater personality change. According to a study published in the Dec. issue of the Archives of General Psychiatry, "patients with major depressive disorder (MDD) taking paroxetine underwent greater personality change than those taking placebo, including a significant reduction in neuroticism and a marked increase in extraversion, even after controlling for depression improvement." Researchers arrived at that conclusion after randomizing "240 MDD patients aged 18 to 70 years to receive paroxetine (n = 120), placebo (n = 60), or cognitive therapy (n = 60)," then following them for a year. Notably, paroxetine "appears to have a positive effect on personality that is separate and distinct from its antidepressant effects."