CHMP backs Eliquis, linaclotide

EMA's CHMP issued several positive opinions on Friday, including recommending approval to expand the indication of a 2.5 mg dose strength of Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and partner Pfizer Inc. (NYSE:PFE) to include the prevention stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors. The committee also recommended approval of a new 5 mg dose strength for the indication. The higher dose is not approved or under review for the lower dose's approved indication -- to prevent venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. In June, FDA issued a complete response letter for the direct Factor Xa inhibitor to prevent stroke and systemic embolism in patients with AF (see BioCentury Extra, June 25). ...