Drugs in the Pipeline

New Hemophilia A Treatment Option to Get FDA Review

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Kovaltry (BAY 81-8973), a recombinant Factor VIII compound for the treatment of hemophilia A in children and adults.

Melanoma Treatment Under Review for Preventing, Delaying Recurrence

The Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy (ipilimumab; Bristol-Myers Squibb) for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection.

FDA to Review Investigational Parkinson's Disease Drug Xadago

The FDA has accepted for filing the New Drug Application (NDA) for Xadago (safinamide; Newron and Zambon) as add-on therapy in both early and mid-to-late stage Parkinson's disease (PD) patients who are inadequately managed on their current treatment.

FDA Wants More Info Before Approving Exparel for Post-Op Nerve Block

The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for the use of Exparel (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia.

First-In-Class Enzyme Replacement Therapy for Hypophosphatasia Under Review

The FDA has accepted for Priority Review the Biologics License Application (BLA) for asfotase alfa in the treatment of patients with infantile-and juvenile-onset hypophosphatasia (HPP).

FDA to Review Lifitegrast for Dry Eye Disease

Shire has submitted a New Drug Application (NDA) to the FDA for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

BI Requesting Accelerated Approval for Pradaxa Reversal Agent

Boehringer Ingelheim announced that it has submitted a Biologics License Application (BLA) to the FDA, requesting accelerated approval for the use of idarucizumab to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).

Harvoni for HCV Genotype 4, HIV Co-Infection Assessed in New Research

Gilead Sciences announced results from ION-4, a Phase 3 study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.

Combo Therapy for HCV, HIV Co-Infection: New Data on Sustained Virologic Response

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase 3 trial evaluating the use of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) co-infected with HIV.

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eisai announced results from a Phase 3 trial investigating the use of eribulin vs. dacarbazine in patients with advanced soft tissue sarcomas.

New Data on Once-Daily Baricitinib for RA From Phase 3 Trial

Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.

Breakthrough Therapy for Rare Enzyme Disorder Could Be Approved Even Sooner

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for Kanuma (sebelipase alfa; Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency (LAL Deficiency).

Shorter FDA Review for Tx of Rare Lung Disorder

The Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Rapamune (sirolimus; Pfizer) for the treatment of lymphangioleiomyomatosis (LAM).

New Oral Combo for Metastatic Colorectal Cancer To Get FDA Review

The Food and Drug Administration (FDA) has accepted Taiho's New Drug Application (NDA) for review for TAS-102 (nonproprietary names: trifluridine and tipiracil HCl) for the treatment of refractory metastatic colorectal cancer (mCRC).

FDA to Review Belbuca for Pain Management

The Food and Drug Administration (FDA) has accepted the NDA for review for Belbuca (buprenorphine HCl; Endo and BioDelivery Sciences) buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.