Drugs in the Pipeline

Drugs in the Pipeline

NBI-98854 Designated Breakthrough Therapy for Tardive Dyskinesia

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for NBI-98854 (Neurocrine Biosciences) for tardive dyskinesia.

Investigational Gene Therapy Designated Orphan Drug for Eye Disorder

The Food and Drug Administration (FDA) has granted Orphan Drug designation to RST-001 for the treatment of retinitis pigmentosa (RP).

Glassia Designated Orphan Drug for Graft-Versus-Host Disease

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).

Sarcoidosis-Associated Small Fiber Neuropathy Therapy Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track status to ARA290 (Araim Pharmaceuticals) for the treatment of Sarcoidosis-associated Small Fiber Neuropathy (SFN).

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).