Raxibacumab- Approved for the treatment of inhalational Anthrax

         
         The U.S FDA today approved raxibacumab a monoclonal antibody in the prophylaxis and treatment of inhalational anthrax. Anthrax is a disease caused by Bacillus anthracis bacteria.Inhalational form is also known as wool sorter’s disease as workers in wool industry inhale the spores of bacillus anthracis while sorting out the wool.Anthrax has also been tried to use as a weapon of bioterrorism.
         Raxibacumab is a chimeric monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis. In case of bioterrorism by the use of anthrax spores, raxibacumab is available along with the antibiotics.
                   More animals treated with raxibacumab lived compared to animals treated with placebo. Sixty-four percent of animals in the monkey study and 44 percent of animals in one rabbit study receiving the 40 milligrams per kilogram dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups. All surviving animals developed toxin-neutralizing antibodies. Another study in rabbits showed that 82 percent of animals treated with antibiotics and raxibacumab survived exposure to anthrax compared with 65 percent of animals receiving antibiotic treatment alone.
             The safety of raxibacumab was evaluated in 326 healthy human volunteers. Common side effects included rash, extremity pain, itching and drowsiness.
        Raxibacumab was developed by Rockville, Md.-based Human Genome Sciences, in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. Human Genome Sciences has since been acquired by GlaxoSmithKline.
Source:http://http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htm
 

FDA approves Signifor® for the treatment of Cushing’s Disease

                                                        Signifor (pasireotide diaspartate) ,an orphan drug ,an analogue of somatostatin has been approved by the FDA for the treatment of Cushing’s disease on 14th Dec 2012. Signifor has been developed by Novartis.

                Cushing’s disease is a condition caused by pituitary adenoma ,which leads to overstimulation of adrenal glands and overproduction of cortisol. Leading to spectrum of signs symptoms including central obesity, buffalo hump,purple striae, altered diurnal variation, hyperglycemia,hypertension hirsutism and many more. There is one more entity called Cushing’s syndrome which has same range of signs and symptoms but caused due to other peripheral causes most commonly being iatrogenic i.e steroid administration.

           Usually Cushing's disease is due to pituitary adenoma or a small tumour which is removed surgically. In patients in whom it cannot removed surgically, Signifor can be given. It is a somatostatin analogue which acts mainly on somatostatin receptor 5. 

               ^{FDA approved Signifor based on the results of PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease).Results from the PASPORT-CUSHINGS study found that a decrease in mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was sustained during the treatment period in most patients with a subset of patients reaching normal levels. The study also showed that certain clinical manifestations of Cushing's disease tended to improve.}

           ^{Signifor is given subcutaneously. The important side effects being hyperglycemia, diarrhea, nausea, abdominal pain, and gallstones.}

 

^{Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htm}