Drugs in the Pipeline

Drugs in the Pipeline

Rare Skin Disorder Therapy Granted Orphan Drug Designation

The FDA has granted Orphan Drug designation to AC-201 for the treatment of epidermolysis bullosa (EB).

FDA to Review Aripiprazole Lauroxil NDA for Schizophrenia

The FDA has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, a once-monthly injectable atypical antipsychotic for the treatment of schizophrenia.

FDA Accepts NDA for Type 2 Diabetes Combo Drug for Filing

The FDA has accepted for filing the NDA for empagliflozin plus immediate-release metformin HCl fixed-dose combination for the treatment of adults with type 2 diabetes.

Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures

The FDA has accepted for review the Supplemental New Drug Application (sNDA) for Fycompa (perampanel; Eisai) for the treatment of primary generalized tonic-clonic (PGTC) seizures.

FDA Fast Tracks Combination Metastatic Colorectal Cancer Drug

The FDA has granted Fast Track designation for trifluridine and tipiracil hydrochloride (TAS-102), an oral combination anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).

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.