Drugs in the Pipeline

Drugs in the Pipeline

FDA Issues Complete Response Letter for Opdivo

The FDA has issued a Complete Response Letter to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab; BMS) as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

FDA to Review Extended-Release Formulation of Lorcaserin

The FDA has accepted for filing the New Drug Application (NDA) for extended-release lorcaserin (Eisai and Arena) as once daily dosing option for chronic weight management.

Results for Lyrica in Post-Traumatic Peripheral Neuropathic Pain Announced

Pfizer announced that a Phase 3 study evaluating the efficacy and safety of Lyrica (pregabalin) Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain did not meet its primary efficacy endpoint.

New IVIG BLA Submitted for Primary Immunodeficiency

Green Cross announced that it has submitted its Biologics License Application (BLA) to the FDA for IVIG-SN (human normal immunoglobulin G) for the treatment of primary immunodeficiency diseases (PID).

FDA Fast Tracks Investigational Tx for Liver Fibrosis

Nitto Denko announced that the FDA has granted two Fast Track designations to ND-L02-s0201 for the treatment of nonalcoholic steatohepatitis (NASH) liver fibrosis and hepatitis C virus (HCV) liver fibrosis.

FDA to Review New Warfarin Formulation

Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.

NDA for Extended-Release Diabetes Tx Submitted

Janssen announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for once-daily Invokamet XR (canagliflozin/metformin extended-release) as a new treatment option for adults with type 2 diabetes mellitus as adjunct to diet and exercise to improve glycemic control.

Novel Tx Granted Orphan Drug Status for Aggressive Brain Cancer

The FDA has granted Orphan Drug designation to marizomib (Triphase Accelerator) for the treatment of malignant glioma, an aggressive form of brain cancer with a significant unmet need due to its poor prognosis.

Avelumab Receives Breakthrough Tx Status for Rare Skin Cancer

The FDA has granted Breakthrough Therapy designation to avelumab (Merck/Pfizer) for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer, who have progressed after at least one previous chemotherapy regimen.

Opdivo Granted Priority Review for Advanced Renal Cancer

The FDA has accepted for filing and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab; BMS) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.