Drugs in the Pipeline

Xarelto sNDA Submitted for VTE Prophylaxis in Acute Medically Ill

Xarelto sNDA Submitted for VTE Prophylaxis in Acute Medically Ill

The sNDA submission was supported by Phase 3 data from the MAGELLAN and MARINER trials which assessed the use of rivaroxaban in preventing VTE in acute medically ill patients while hospitalized and immediately after discharge.

Baricitinib Gets Fast Track Status for Systemic Lupus Erythematosus

Baricitinib Gets Fast Track Status for Systemic Lupus Erythematosus

Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.

FDA to Review Lumateperone for Treatment of Schizophrenia

FDA to Review Lumateperone for Treatment of Schizophrenia

Lumateperone and follow-on compounds are also being evaluated for bipolar depression, behavioral disturbance associated with dementia, sleep disturbances associated with neuropsychiatric disorders, and other neuropsychiatric conditions including major depressive disorder and autism.

Oral JAK/SYK Inhibitor Granted Fast Track Designation for Atopic Dermatitis

Oral JAK/SYK Inhibitor Granted Fast Track Designation for Atopic Dermatitis

The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational oral dual inhibitor, ASN002 (Asana BioSciences), for the treatment of moderate-to-severe atopic dermatitis.

Novel H. pylori Eradication Therapy Effective in Phase 3 Trial

Novel H. pylori Eradication Therapy Effective in Phase 3 Trial

The ERADICATE Hp2 trial enrolled 455 dyspepsia patients at 55 sites across the US and randomized them to receive 4 capsules, 3 times daily, of either Talicia or the active comparator (amoxicillin 250mg and omeprazole 10mg), for a period of 14 days.

Rimegepant Zydis ODT Beneficial in Phase 3 Migraine Trial

Rimegepant Zydis ODT Beneficial in Phase 3 Migraine Trial

In Study 303 (N=1375), rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, achieved statistical significance in 2 co-primary endpoints: pain freedom and freedom from most bothersome symptom (MBS).

FDA Grants Orphan Drug Designation to Huntington Disease Treatment

FDA Grants Orphan Drug Designation to Huntington Disease Treatment

In animal studies, the treatment was associated with improvement in both motor and cognitive function.

FDA to Review Estrogen-Free Oral Contraceptive Slinda

FDA to Review Estrogen-Free Oral Contraceptive Slinda

Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity.

Novel NASH Treatment Gets FDA's Fast Track Designation

Novel NASH Treatment Gets FDA's Fast Track Designation

The Company has completed a first in human study in healthy volunteers; a Phase 2 trial in adults with NASH is due to begin soon in the US.

FDA Fast Track Designation Granted for Investigational Osteoarthritis Treatment

FDA Fast Track Designation Granted for Investigational Osteoarthritis Treatment

The FDA has granted Fast Track designation for GLPG1972/S201086 for the treatment of patients with osteoarthritis.

Treatment for Primary Sclerosing Cholangitis Gets Orphan Drug Status

Treatment for Primary Sclerosing Cholangitis Gets Orphan Drug Status

Primary sclerosing cholangitis (PSC) is a rare, chronic and progressive liver disorder that often occurs in the setting of inflammatory bowel disease.

Novel Antiviral Pimodivir Evaluated in Patients With Acute Uncomplicated Influenza A

Novel Antiviral Pimodivir Evaluated in Patients With Acute Uncomplicated Influenza A

To evaluate the safety and antiviral activity of the treatment, patients in the TOPAZ trial (N=292) were randomized to receive pimodivir 300mg or 600mg, pimodivir 600mg plus oseltamivir 75mg, or placebo twice daily for 5 days.

FDA Panel Votes in Favor of Abuse-Deterrent Oxycodone Reformulation

FDA Panel Votes in Favor of Abuse-Deterrent Oxycodone Reformulation

The vote was taken in a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.

Lasmiditan NDA Submitted for Acute Treatment of Migraine

Lasmiditan NDA Submitted for Acute Treatment of Migraine

The NDA submission included data from two Phase 3 trials, SAMURAI and SPARTAN.

Glecaprevir/Pibrentasvir 8-Week Regimen Evaluated in Treatment-Naïve HCV Patients With Compensated Cirrhosis

Glecaprevir/Pibrentasvir 8-Week Regimen Evaluated in Treatment-Naïve HCV Patients With Compensated Cirrhosis

In EXPEDITION-8, 280 treatment-naïve HCV patients (genotypes 1, 2, 4, 5, and 6) with compensated cirrhosis were treated with Mavyret for 8-weeks; the primary efficacy measure was SVR12 rate.