Drugs in the Pipeline

Rapid Reversal Seen With Idarucizumab in Pradaxa-Treated Patients

Boehringer Ingelheim presented positive results of its Phase 3 RE-VERSE AD study for idarucizumab as a reversal agent for the anticoagulant effect of Pradaxa (dabigatran) in patients needing emergency surgery or for life-threatening or uncontrolled bleeding events.

Elotuzumab BLA Given Priority Review for Multiple Myeloma

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Empliciti (elotuzumab, Bristol-Myers Squibb/AbbVie) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.

Biologic Tx BLA Accepted for Bladder Cancer

The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.

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).