Drugs in the Pipeline

Letairis/Tadalafil Combo Demonstrates Efficacy for Pulmonary HTN

Gilead Sciences announced positive results from the AMBITION study, a Phase 3/4 trial of first-line combination therapy with Letairis (ambrisentan) and tadalafil in patients with WHO/NYHA functional class II and III pulmonary arterial hypertension (PAH).

Novel Antibiotic Fast Tracked for Bacterial Vaginosis

The Food and Drug Administration (FDA) has granted SYM-1219 (secnidazole, Symbiomix) Fast Track designation for the treatment of bacterial vaginosis (BV).

FDA Accepts Eteplirsen NDA for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for eteplirsen (Sarepta) for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

Novel Drug Granted Orphan Designation for Rare Musculoskeletal Disorder

The Food and Drug Administration (FDA) has granted AT001 (Audentes) Orphan Drug designation for the treatment of X-Linked Myotubular Myopathy (XLMTM).

Positive Results for First Long-Acting Injection-Free GLP-1 Agonist

Intarcia Therapeutics has announced that the Phase 3 trial of ITCA 650 (exenatide) demonstrated positive top-line results in reducing HbA1c in patients with type 2 diabetes following a year of treatment.

Anti-PDL1 Immunotherapy Demonstrates Efficacy in Phase 2 NSCLC Study

Genentech announced that the Phase 2 study of atezolizumab met its primary endpoint and shrank tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1).

BromSite NDA Accepted for Post-Cataract Surgery

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for BromSite (0.075% bromfenac; InSite Vision) for the treatment of inflammation and prevention of ocular pain post-cataract surgery.

FDA Accepts Keytruda sBLA for First-Line Melanoma Indication

The Food and Drug Administration (FDA) has accepted for review the sBLA for Keytruda (pembrolizumab, Merck) for the first-line treatment of unresectable or metastatic melanoma patients.

New Microbiome Therapy Granted Orphan Drug Designation for Recurrent CDI

New Microbiome Therapy Granted Orphan Drug Designation for Recurrent CDI

The Food and Drug Administration (FDA) has granted Orphan Drug designation to SER-109 (Seres Therapeutics) for the prevention of recurrent Clostridium difficile infection (CDI) in adults.

Adjunctive Fycompa Demonstrates Efficacy in PGTC Seizures

The Phase 3 trial for Fycompa (perampanel, Eisai) demonstrated statistically significant results when used as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 12 years and older.

Cabozantinib Receives Breakthrough Therapy Designation for Renal Cancer

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to cabozantinib (Exelixis) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

Investigational Agent for Huntington's Disease to Be Reviewed by FDA

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SD-809 (deutetrabenazine, Teva) for the treatment of chorea associated with Huntington's disease (HD).

Venetoclax Demonstrates Efficacy in Phase 2 CLL Study

The Phase 2 trial of venetoclax (AbbVie) has met its primary endpoint in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

Brintellix sNDA Accepted for Labeling Update on Cognitive Effects

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Brintellix (vortioxetine, Takeda and Lundbeck) to add to the current labeling its effects on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD).

Recombinant IVIG granted Orphan Drug Designation for CIDP

The Food and Drug Administration (FDA) has granted GL-2045 (recombinant Intravenous Immune Globulin, Gliknik/Pfizer) Orphan Drug designation for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).