Drugs in the Pipeline

Eylea Shows Greater Visual Acuity Gain in DME Trial

Regeneron announced results from an effectiveness study sponsored by the National Institutes of Health (NIH) in patients with diabetic macular edema (DME) treated with Eylea (aflibercept) Injection compared to Avastin (bevacizumab; Genentech) and Lucentis (ranibizumab; Genentech).

Investigational Radiotracer Designated Orphan Drug for Neuroendocrine Tumors

The Food and Drug Administration (FDA) has granted Orphan Drug designation to OPS202 (OctreoPharm Sciences), an investigational radiotracer, based on a next generation antagonistic somatostatin analog for the management of neuroendocrine tumors.

Lenvatinib NDA Under Review for RAI-Refractory Differentiated Thyroid Cancer

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lenvatinib mesylate (Eisai) for the treatment of progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) and granted the NDA Priority Review status.

Orexo Seeks to Expand Zubsolv Labeling

Orexo AB announced that it has submitted an application to the Food and Drug Administration (FDA) for an expanded label of Zubsolv (buprenorphine/naloxone) sublingual tablet CIII to include initiation of treatment for opioid dependence.

Palbociclib + Letrozole NDA Under Review for Advanced Breast Cancer

The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the NDA for palbociclib in combination with letrozole, as a first-line treatment of postmenopausal women with ER+, HER- advanced breast cancer who have not received previous systemic treatment for their advanced disease.

Blinatumomab BLA to be Reviewed for Acute Lymphoblastic Leukemia

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for blinatumomab for the treatment of adults with Philadelphia-negative (PH-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Lefamulin Designated QIDP and Fast Track Status for Bacterial Infections

The Food and Drug Administration (FDA) has designated lefamulin (Nabriva) as a Qualified Infectious Disease Product (QIDP) and has been granted Fast Track status for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Adalimumab Biosimilar Meets Endpoint in Plaque Psoriasis Study

Amgen announced that its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared to Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.

NurOwn Granted Fast Track Status for ALS

The Food and Drug Administration (FDA) has granted Fast Track status to NurOwn (BrainStorm Cell Therapeutics) for the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's Disease).

Oncolytic Adenovirus Designated Orphan Drug for Malignant Glioma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DNX-2401 (DNAtrix), a conditionally-replicative oncolytic adenovirus for malignant glioma.

PEGPH20 Designated Orphan Drug for Pancreatic Cancer

Halozyme Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to PEGPH20 (PEGylated recombinant human hyaluronidase) for the treatment of pancreatic cancer.

Investigational Pump Efficacious in Type 2 Diabetes Trials

Intarcia Therapeutics announced top-line results from two of its four Phase 3 clinical trials for ITCA 650 (continuously subcutaneous delivery of exenatide) for patients with type 2 diabetes.

ALK+ Metastatic NSCLC Therapy Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AP26113 (ARIAD Pharmaceuticals) for the treatment of anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

Investigational Sickle Cell Disease Agent Fast Tracked

The Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease.

Avedro Resubmits NDA for Eye Disorders

Avedro announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for riboflavin ophthalmic solution/KXL System for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.