Drugs in the Pipeline

Drugs in the Pipeline

Opdivo sBLA Under Priority Review for New Melanoma Indication

The Food and Drug Administration (FDA) has accepted for filing and has granted Priority Review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma.

New Brilinta Indication Accepted for Priority Review

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor; AstraZeneca) tablets for patients with a history of heart attack.

New Tx for Relapsing MS Moves Closer to Approval as FDA Accepts BLA for Review

The Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review for Zinbryta (daclizumab high-yield process; Biogen and AbbVie) in relapsing forms of multiple sclerosis (MS).

Rare Lysosomal Disorder Therapy Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation for the development of GZ/SAR402671 (Genzyme), an oral substrate reduction therapy for the treatment of Fabry disease.

CRLX101 Fast Tracked for Metastatic Renal Cell Carcinoma

The Food and Drug Administration (FDA) has granted Fast Track designation to CRLX101 (Cerulean Pharma) in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.

Investigational Shingles Vaccine Effective Across Older Age Groups

GlaxoSmithKline announced results from the Phase 3 ZOE-50 trial of HZ/su, an investigational vaccine for the prevention of herpes zoster in older adults.

Viekirax + Exviera Demonstrates Virologic Response in HCV Trial

Enanta announced results from AbbVie's ongoing, Phase 3b RUBY-1 study evaluating Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) with or without ribavirin (RBV) in treatment naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis.

SVR12 With Combo Hepatitis C Therapy for Cirrhosis Patients in Study

Bristol-Myers Squibb announced results from the ALLY-1 Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) infection with either advanced cirrhosis or post-liver transplant recurrence of HCV.

Rare Facial Disorder Drug Designated Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma), a physiocrine-based product for the treatment of facioscapulohumeral muscular dystrophy (FSHD).

Rare Inherited Liver Disorder Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1).