Drugs in the Pipeline
Eli Lilly and Incyte announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA).
The Food and Drug Administration (FDA) has accepted for filing with Priority Review the New Drug Application (NDA) for defibrotide for the treatment of patients with hepatic veno-occlusive disease (VOD) with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).
The FDA has accepted for filing the New Drug Application (NDA) for Ontinua ER (arbaclofen; Osmotica) extended-release tablets for alleviation of spasticity associated with multiple sclerosis.
Lilly announced that the Phase 2 study of Cyramza (ramucirumab) in combination with docetaxel met its primary endpoint for patients with locally advanced or who failed prior platinum-based therapy.
The Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for eribulin mesylate (Eisai) for the treatment of patients with inoperable soft tissue sarcoma (leiomyosarcoma and liposarcoma) who have received prior chemotherapy for advanced or metastatic disease.
The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab; BMS) + Yervoy (ipilimumab; BMS) regimen to include clinical data from the CheckMate -067 trial of patients with previously untreated advanced melanoma.
Bristol-Myers Squibb announced positive results from CheckMate -025, a Phase 3 study comparing Opdivo (nivolumab) to everolimus in advanced renal cell carcinoma (RCC) after prior anti-angiogenic treatment.
The New Drug Application (NDA) for Dextenza (sustained release dexamethasone; Ocular Therapeutix) 0.4mg Intracanalicular Depot has been submitted to the FDA for the treatment of ocular pain following ophthalmic surgery.
Genentech announced positive results from a pivotal Phase 3 study, ORATORIO, which evaluated the investigational drug ocrelizumab for the treatment of primary progressive multiple sclerosis (PPMS).
The FDA has granted Orphan Drug designation to the investigational cancer immunotherapy avelumab (Pfizer/Merck) for the treatment of Merkel cell carcinoma (MCC).