The FDA has approved the use of Synjardy (empagliflozin and metformin hydrochloride) tablets in treatment-naive adults with type 2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control. Synjardy has already been approved for adults with T2D who are not adequately controlled on a regimen containing empagliflozin or metformin. The drug has been developed under the diabetes collaboration between Eli Lilly (LLY) and Germany-based Boehringer Ingelheim. It is a combination of Jardiance (empagliflozin) and metformin.
Cerulean Pharma (CERU) announced that the FDA has granted its Phase 1/2-stage CRLX101, a Fast Track status for the treatment of platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.
ProQR Therapeutics (PRQR) announced that the FDA has granted its Phase 1b-stage QR-010 for Fast Track review for the treatment of cystic fibrosis (CF) patients who have the delta F508 mutation. QR-010 is an inhaled therapy designed to repair the genetic defect in RNA which will result in the synthesis of a normal healthy CFTR protein.
The FDA has approved the expanded use of Allergan’s (AGN) NAMZARIC (memantine hydrochloride and donepezil hydrochloride) extended-release capsules in patients with moderate-to-severe Alzheimer's disease (AD) who are currently stabilized on Aricept (donepezil hydrochloride), allowing them to directly start combination therapy. The drug was approved earlier or moderate-to-severe AD patients who are currently taking memantine HCl and donepezil HCl.
AstraZeneca (AZN) announced that the European Commission (EC) has approved its fixed-dose combination of saxagliptin and dapagliflozin, branded as Qtern, for the treatment of adults with type 2 diabetes (T2D).