Argenx gets green cue in phase 2 in primary immune thrombocytopenia
The Belgian biotech, Argenx has cleared phase 2 data on efgartigimod in primary immune thrombocytopenia (ITP). The results that they received, indicate at the effectiveness of the antibody Fc fragment in patients with the autoimmune bleeding disorder. ITP patients suffer from low platelet counts. If platelet levels plunge, then bleeding inside the brain can cause serious complications. Doctors manage the disease by using either corticosteroids or SYK inhibitor Tavalisse of Rigel Pharmaceuticals, but Argenx ruminates of safer and more broadly effective therapy. To this, Chief Medical Officer of Argenx apprise of Efgartigimod being the potential to address ITP in a unique way across patient types, targeting disease at the source by removing IgGs and restoring platelet numbers.
FDA uplifts clinical hold from breast cancer trial of Mersana Therapeutics
The FDA has lifted the partial clinical hold from phase 1 of HER2-targeted antibody-drug conjugate (ADC) of Mersana Therapeutics. It was on hold due to death of a participant in the XMT-1522 breast cancer trial. Mersana has come out from the partial hold by approving to increase monitoring and eliminate patients with advanced hepatic impairment from the trial.
FDA takes time to review levodopa inhaler of Acorda for Parkinson’s disease
FDA has extended the review of Acorda Therapeutics’ drug-device combination treatment for Parkinson’s disease. As, FDA asked for additional information on chemistry, manufacturing and controls, so, the chief amendment to its application will take more time to review.
FDA clears first rescue stent to seal coronary artery tears
The FDA permitted a new emergency stent device to treat perforations in the blood vessels of the heart. Deep tears in coronary arteries can arise in rare instances during percutaneous interventions, where stents are inserted through a catheter to enlarge narrowed vessels to increase blood flow to the heart.